Anti-NMDA Receptor EncephalitisAMENDSNCT06183788
Antibody-mediated NMDA Receptor Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Prolonged Recovery Stage
A study testing Remote cognitive rehabilitation program in people with Anti-NMDA Receptor Encephalitis, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
The encephalitis mediated by antibodies against the NMDA receptor (NMDARe) predominantly affects young adults and children resulting in severe neurologic and psychiatric deficits. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Anti-NMDA Receptor Encephalitis
- What is being tested?
- Remote cognitive rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ≥12 years old with NMDARe in the post-acute stage of the disease;
- ≤6 months from hospital discharge (acute phase)
Who cannot join
- Inability to obtain informed consent;
- inability to travel to the center.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
Josep Dalmau, MD, PhD, +34 93 227 1738, jdalmau@clinic.cat
Victor Patricio, MS, +34 93 227 1738, vpatricio@recerca.clinic.cat
About this study
The encephalitis mediated by antibodies against the NMDA receptor (NMDARe) predominantly affects young adults and children resulting in severe neurologic and psychiatric deficits. After overcoming the acute stage, patients are left with long-lasting behavioral, cognitive, and psychiatric alterations with important socio-family-economical implications. Here investigators postulate that a better knowledge of this stage will improve treatment decisions and outcome.
In Aim 1, the post-acute stage will be clinically characterized, tools to remotely follow cognitive, behavioral and psychiatric deficits will be provided, and the impact of cognitive rehabilitation will be assessed.
Read more
In Aim 2, biomarkers (autoimmune, inflammatory, neuronal injury) will be identified as signatures of the acute and post-acute stages.
In Aim 3, a mouse model of NMDARe will be used to determine the underlying mechanisms and treatment of the postacute stage.
- Conditions
- Anti-NMDA Receptor Encephalitis
- Being tested
- Remote cognitive rehabilitation program
- Keywords
- Cognitive Impairment, Encephalitis, Autoimmune, Cognitive rehabilitation
- Medical subject headings
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Cognitive Dysfunction, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote cognitive rehabilitation programBehavioural
Remote cognitive rehabilitation program will be performed through an online validated platform (Guttmann NeuroPersonalTrainer: https://gnpt.es/) run by the psychologists team. This is a Sanitary Product with CE certification (Sanitary Product RPS/430/2014; International Patent [PCT/ES2008/00677]) and here will be used within its approved indications. The rehabilitation program will increase in difficulty and decrease in frequency during the first year of follow-up (V1-V3).
| Study group | Role | What they receive |
|---|---|---|
| Anti-NMDARe patients with remote cognitive rehabilitation | Experimental | Participants of a prospective cohort in post-acute phase of the Antibody-mediated NMDA Receptor Encephalitis that will received a behavioral treatment. Receives: Behavioral: Remote cognitive rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age measured in years
Measured: 18 months
Gender
Male or female
Measured: 18 months
Vision condition
Studied by optometer
Measured: 18 months
Handedness
Right- or Left-handed
Measured: 18 months
General medical history
Description of the most important issues compiled in the general medical history of the participant
Measured: 18 months
Allergies
List of allergies of each participant
Measured: 18 months
Symptoms related to NMDARe
Detailed description of symptoms experienced before, during and after the post-acute phase of NMDARe.
Measured: 18 months
Treatments
All treatments in which the participant is being involved.
Measured: 18 months
Functional status
Functional status according to Modified Rankin Scale (mRS)
Modified Rankin Scale:
- Range: from 0 points (no symptoms) to 6 points (dead).
Measured: 18 months
Intelligence Quotient
Estimated through General Ability Index (GAI; from Weschler Adult Intelligence Scale - IV (WAIS-IV).
This index is obtained through Verbal Comprehension Index (VCI) and Perceptual Reasoning Index (PRI).
- Range of GAI: from 40 to 160. Higher is better.
- Range of VCI: from 50 to 150. Higher is better.
- Range of PRI: from 50 to 150. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Verbal working memory
Verbal Working Memory: Working Memory Index (WMI) from WAIS-IV.
- Range of WMI: from 50 to 150. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Phonological loop
Assessed by Forward order span of Digit span subtest from WAIS-IV.
- Range: from 0 to 9
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Visual working memory
Visual Working Memory: Spatial location subtest from Weschler Memory Scale - IV (WMS-IV).
- Range of Spatial Location subtest: from 0 to 32. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Verbal learning
Assessed by:
Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI)
- Total learning: range: from 0 to 80. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Proactive interference verbal memory
Assessed by:
Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI)
- Interference list: range: 0 to 15. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Short-term verbal memory
Assessed by:
Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI)
- Short-term memory free recall: range: 0 to 15. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Long-term verbal memory
Assessed by:
Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI)
- Long-term memory free recall: range: 0 to 15. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Verbal recognition memory
Assessed by:
Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI)
- Word-list Recognition: range: 0 to 15. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Verbal discrimination memory
Assessed by:
Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI)
- Discrimination index of word-list: False positives + omissions of recognition between 44 total words to recognize. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Verbal retention memory
Assessed by:
Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI)
- Retention index: percentatge of Long-term memory free recall between Short-term memory free recall. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Immediate visual memory
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R)
- Immediate visual memory: range: from 0 to 36. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Delayed visual memory
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R)
- Delayed visual memory: range: from 0 to 12. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Visual retention memory
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R)
- Retention index: percentatge of Long-term memory free recall between the Higher punctuation at Trial 2 or 3. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Visual recognition memory
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R)
- Figure Recognition: range: from 0 to 6. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Visual discrimination memory
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R)
- Discrimination index: figure recognized minus false positives. Range: from -6 to 6. Higher is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Processing speed
Processing speed Index (PSI; from Weschler Adult Intelligence Scale - IV (WAIS-IV).
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
TMT-A
Trail Making Test part A (TMT-A):
- Time in seconds: from 0 to infinity.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
TMT-B
Trail Making Test part B (TMT-B):
- Time in seconds: from 0 to infinity.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Naming
Assessed by: Boston Naming Test (BNT)
- Total correct: from 0 to 60
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Naming with cues
Assessed by: Boston Naming Test (BNT)
- Total correct with phonemic cue: from 0 to 60
Measured: 18 months
Latency in naming
Assessed by: Boston Naming Test (BNT)
- Time to complete test in seconds
Measured: 18 months
Semantic fluency
Number of name of animals recalled in 1 minute: range: from 0 to infinity. (Test Barcelona - Revised) (for ADULTS) Number of name of animals recalled in 1 minute + number of name of food and drinks recalled in 1 minute: from 0 to infinity (NEPSY - II) (for CHILDREN)
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Phonemic fluency
Number of words started by letter "M" recalled in 1 minute: Range: from 0 to infinity. (Test Barcelona-Revised) (for ADULTS) Number of words started by letter "P" recalled in 1 minute + number of words started by letter "M" in 1 minute: range: from 0 to infinity (NEPSY-II) (for CHILDREN).
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Visuospatial skills
Number location subtest of the Visual-Object Spatial and Perceptual battery.
- Range: from 0 to 10
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Visuospatial skills - children
Assessed by Arrows subtest of NEPSY-2 battery
- Range: from 0 to 20
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Stroop test - word subtest
- Words: words read in 45 seconds
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Stroop test - color subtest
- Colour: colours distinguished in 45 seconds.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Stroop test - word-color subtest
- Word-colour: colours distinguished in 45 seconds.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Detectability - CPT3
Assessed by Continuous Performance Test - 3rd Version.
Measures the respondent's ability to differentiate non-targets (i.e. the letter X) from targets (i.e. all other letters).
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Omissions - CPT3
Assessed by Continuous Performance Test - 3rd Version.
Result from a failure to respond to targets.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Comissions - CPT3
Assessed by Continuous Performance Test - 3rd Version.
Comissions are made when responses are given to non-targets.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
HRT - CPT3
Assessed by Continuous Performance Test - 3rd Version.
Hit Reaction Time (HRT) is the mean response speed of correct responses from the whole administration.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
HRT-SD - CPT3
Assessed by Continuous Performance Test - 3rd Version.
Hit Reaction Time Standard Deviation (HRT-SD) is a measure of response speed consistency during the entire administration.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Variability- CPT3
Assessed by Continuous Performance Test - 3rd Version.
The amount of variability that the patient showed in 18 separate segments of the administration in relation to their own overall Hit Reaction Time Standard Deviation (HRT-SD).
It is a measure of response consistency and a "within respondent" measure".
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
HRT Block Change - CPT3
Assessed by Continuous Performance Test - 3rd Version.
Hit Reaction Time Block Change indicates the change in mean response speed across blocks.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
HRT ISI Change - CPT3
Assessed by Continuous Performance Test - 3rd Version.
Hit Reaction Time Inter-Stimulus Interval Change (HRT ISI Change) indicates the change in mean response speed at various ISIs.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Prensence of psychiatric symptoms or disorders in presential assessments
Number of participants with psychiatric symptoms/disorders following DSM-IV-TR guidelines (psychotic symptoms, symptoms of depression, symptoms of mania, global functioning).
Measured: 18 months
Sleep microstructure - Total study time
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Total sleep time: minutes
Measured: 18 months
Sleep microstructure - Total sleep time
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Total sleep time: minutes
Measured: 18 months
Sleep microstructure - Sleep efficiency
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Sleep efficiency: based on total study time and total sleep time
Measured: 18 months
Sleep microstructure - Time to sleep onset
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Time to sleep onset: minutes
Measured: 18 months
Sleep microstructure - Time in stage N1
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Time in stage N1: minutes
Measured: 18 months
Sleep microstructure - Time in stage N2
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Time in stage N2: minutes
Measured: 18 months
Sleep microstructure - Time in stage N3
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Time in stage N3: minutes
Measured: 18 months
Sleep microstructure - Time in stage R
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Time in stage R: minutes
Measured: 18 months
Sleep microstructure - First epoch of N1
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- First epoch of N1: minutes
Measured: 18 months
Sleep microstructure - First epoch of N2
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- First epoch of N2: minutes
Measured: 18 months
Sleep microstructure - First epoch of N3
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- First epoch of N3: minutes
Measured: 18 months
Sleep microstructure - First epoch of REM
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- First epoch of REM: minutes
Measured: 18 months
Sleep microstructure - REM/NREM time ratio
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- REM/NREM time ratio
Measured: 18 months
Sleep microstructure - Number of arousals
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Number of arousals (total)
Measured: 18 months
Sleep microstructure - Arousal Index
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Arousal Index
Measured: 18 months
Sleep microstructure - Confusional arousals
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Confusional arousals: Yes or No
Measured: 18 months
Sleep microstructure - Direct transition from N3 to W
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Direct transition from N3 to W: yes or no
Measured: 18 months
Sleep microstructure - Delta arousals
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- "Delta arousals"?: yes, no or unknown
Measured: 18 months
Sleep microstructure - Wake after sleep
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported.
Parameters:
- Wake after sleep: hour
Measured: 18 months
Adherence to cognitive treatment - 6 months
Number of sessions performed in 6 months
Measured: 6 months
Adherence to cognitive treatment - 9 months
Number of sessions performed in 9 months
Measured: 9 months
Adherence to cognitive treatment - 12 months
Number of sessions performed in 12 months
Measured: 12 months
Secondary outcomes (83)
Immune/inflammatory signaling-target gene expression pathways
Whole blood/CSF will be collected using PAXgene® Blood RNA Tubes (Qiagen) shipped to the centers. Blood from healthy subjects and CSF from patients with normal pressure hydrocephalus will serve as controls.
Total RNA will be extracted using PAXgene® Blood RNA Kit (Qiagen). RNA samples are quantified using Qubit 2.0 Fluorometer (Life Technologies) and RNA integrity is determined with Agilent 2100 Bioanalyzer (Agilent Technologies).
Expression levels of 44 genes related to immune/inflammatory (or cytokine) pathways will be measured with the nCounter® Digital Analyzer (NanoString).
The raw copy number of mRNA transcripts of each gene will be standardized (stdGene) using the geometric mean of the 4 housekeeping genes for each subject.
Measured: 18 months
Neurofilament light chain (NfL) levels in acute stage
Signature of molecular biomarkers in the acute stage
Measured: 18 months
Neurofilament light chain (NfL) levels in post-acute stage
Signature of molecular biomarkers in the post-acute stages
Measured: 18 months
Cell immunophenotyping - proportion of CD4
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of CD4.
Measured: 18 months
Cell immunophenotyping - proportion of CD8
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of CD8.
Measured: 18 months
Cell immunophenotyping - proportion of CD8+CD45RA+
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of CD8+CD45RA+.
Measured: 18 months
Cell immunophenotyping - proportion of CD8+CD45RO+
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of CD8+CD45RO+.
Measured: 18 months
Cell immunophenotyping - proportion of iNKT
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of iNKT.
Measured: 18 months
Cell immunophenotyping - proportion of CD19
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of CD19.
Measured: 18 months
Cell immunophenotyping - proportion of B naive (IgM+IgD+CD27-)
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of B naive (IgM+IgD+CD27-).
Measured: 18 months
Cell immunophenotyping - proportion of B memory (IgD-)
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of B memory (IgD-).
Measured: 18 months
Cell immunophenotyping - proportion of regulatory B cells
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of regulatory B cells.
Measured: 18 months
Cell immunophenotyping - proportion of plasmablasts
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of plasmablasts.
Measured: 18 months
Cell immunophenotyping - proportion of NK cells
Whole blood/CSF obtained in a EDTA tube will be analyzed in a FACS Canto II cytometer to assess the proportion of NK cells.
Measured: 18 months
MRI
It will be conducted on a 3 Tesla Prisma scanner using a 32-channel head coil. Scanning takes ~50 min including 3D T1-weighted in sagittal plane; T2*axial EPI; axial diffusion weighted EPI; 3D sagittal FLAIR; resting state functional MRI and glutamate and H2O univoxel spectroscopy in dorsolateral prefrontal cortex and hippocampus. There is no contrast used for the MRI scans
Outcome for MRI is normal or abnormal. Investigators will review all MRI sequences and determine if the MRI is abnormal and then describe the abnormality or abnormalities seen.
Measured: 18 months
EEG: normalcy
It will include standard clinical EEG protocol (43 channels, 512 Hz18) (primary variables), and EEG reactivations of memories prior to new trials (secondary variables) while participants perform WM tasks, which will be synchronized with the task software in a laptop. The memory content from alpha power across electrodes will be related to the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Performances of the subjects produces a reactivation of memory prior to new trials while participants perform working memory tasks, and relate the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
- Normalcy: yes or no.
Measured: 18 months
EEG: time awake
It will include standard clinical EEG protocol (43 channels, 512 Hz18) (primary variables), and EEG reactivations of memories prior to new trials (secondary variables) while participants perform WM tasks, which will be synchronized with the task software in a laptop. The memory content from alpha power across electrodes will be related to the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Performances of the subjects produces a reactivation of memory prior to new trials while participants perform working memory tasks, and relate the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Parameters:
- Time awake: percentage
Measured: 18 months
EEG: time in drowsiness
It will include standard clinical EEG protocol (43 channels, 512 Hz18) (primary variables), and EEG reactivations of memories prior to new trials (secondary variables) while participants perform WM tasks, which will be synchronized with the task software in a laptop. The memory content from alpha power across electrodes will be related to the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Performances of the subjects produces a reactivation of memory prior to new trials while participants perform working memory tasks, and relate the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Parameters:
- Time in drowsiness: percentage
Measured: 18 months
EEG: time asleep
It will include standard clinical EEG protocol (43 channels, 512 Hz18) (primary variables), and EEG reactivations of memories prior to new trials (secondary variables) while participants perform WM tasks, which will be synchronized with the task software in a laptop. The memory content from alpha power across electrodes will be related to the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Performances of the subjects produces a reactivation of memory prior to new trials while participants perform working memory tasks, and relate the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Parameters:
- Time asleep: percentage
Measured: 18 months
EEG: epileptiform activity
It will include standard clinical EEG protocol (43 channels, 512 Hz18) (primary variables), and EEG reactivations of memories prior to new trials (secondary variables) while participants perform WM tasks, which will be synchronized with the task software in a laptop. The memory content from alpha power across electrodes will be related to the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Performances of the subjects produces a reactivation of memory prior to new trials while participants perform working memory tasks, and relate the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Parameters:
- Epileptiform activity: yes or no
Measured: 18 months
EEG: seizures
It will include standard clinical EEG protocol (43 channels, 512 Hz18) (primary variables), and EEG reactivations of memories prior to new trials (secondary variables) while participants perform WM tasks, which will be synchronized with the task software in a laptop. The memory content from alpha power across electrodes will be related to the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Performances of the subjects produces a reactivation of memory prior to new trials while participants perform working memory tasks, and relate the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Parameters:
- Seizures: yes or no
Measured: 18 months
EEG: slowing
It will include standard clinical EEG protocol (43 channels, 512 Hz18) (primary variables), and EEG reactivations of memories prior to new trials (secondary variables) while participants perform WM tasks, which will be synchronized with the task software in a laptop. The memory content from alpha power across electrodes will be related to the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Performances of the subjects produces a reactivation of memory prior to new trials while participants perform working memory tasks, and relate the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Parameters:
- EEG slowing: yes or no
Measured: 18 months
EEG: Changes with Intermittent Light Stimulation
It will include standard clinical EEG protocol (43 channels, 512 Hz18) (primary variables), and EEG reactivations of memories prior to new trials (secondary variables) while participants perform WM tasks, which will be synchronized with the task software in a laptop. The memory content from alpha power across electrodes will be related to the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Performances of the subjects produces a reactivation of memory prior to new trials while participants perform working memory tasks, and relate the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Parameters:
- Changes with Intermittent Light Stimulation: yes or no
Measured: 18 months
EEG: Changes with hyperventilation
It will include standard clinical EEG protocol (43 channels, 512 Hz18) (primary variables), and EEG reactivations of memories prior to new trials (secondary variables) while participants perform WM tasks, which will be synchronized with the task software in a laptop. The memory content from alpha power across electrodes will be related to the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Performances of the subjects produces a reactivation of memory prior to new trials while participants perform working memory tasks, and relate the decoding accuracy in different task periods to disease treatment and recovery and to behavioral parameters (WM precision, serial biases).
Parameters:
- Changes with hyperventilation: yes or no
Measured: 18 months
Verbal working memory - remote assessment
Assessed by:
Digit subtest from WAIS-IV: obtained by Forward order, indirect order, increasing order subtests.
- Range: 0 - 48
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Verbal learning - remote assessment
Assessed by:
Total learning List A subtest from Rey Auditory Verbal Learning Test (RAVLT)
- Range: 0 - 75
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Proactive interference verbal memory - remote assessment
Assessed by:
List B subtest from Rey Auditory Verbal Learning Test (RAVLT)
- Range: 0 - 15
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Short-term verbal memory - remote assessment
Assessed by:
Short-term verbal memory subtest from Rey Auditory Verbal Learning Test (RAVLT)
- Range: 0 - 15
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Long-term verbal memory - remote assessment
Assessed by:
Long-term verbal memory subtest from Rey Auditory Verbal Learning Test (RAVLT)
- Range: 0 - 15
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Verbal recognition memory - remote assessment
Assessed by:
Verbal recognition memory list subtest from Rey Auditory Verbal Learning Test (RAVLT)
- Range: 0 - 15
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Verbal discrimination memory - remote assessment
Assessed by:
Verbal discrimination memory subtest from Rey Auditory Verbal Learning Test (RAVLT)
- Range: 0 - 1
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Complex figure copy - remote assessment
Assessed by:
Precision in the copy of the Rey-Osterrieth Complex Figure:
- Range: 0-36
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Time - Complex figure copy - remote assessment
Assessed by:
Time to perform the copy of the Rey-Osterrieth Complex Figure: seconds
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Type - Complex figure copy - remote assessment
Assessed by:
Type of copy of the Rey-Osterrieth Complex Figure:
- Range: 1 to 4
Measured: 18 months
Short-term visual memory - remote assessment
Assessed by:
Short term memory subtest of the Rey-Osterrieth Complex Figure:
- Range: 0 - 36
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Long-term visual memory - remote assessment
Assessed by:
Long-term memory subtest of the Rey-Osterrieth Complex Figure:
- Range: 0 - 36
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Orientation in time - remote assessment
Assessed by:
Orientation in time subtest from Test Barcelona - Revised.
- Range: 0 - 5
Higher is better.
Measured: 18 months
Orientation in space - remote assessment
Assessed by:
Orientation in space subtest from Test Barcelona - Revised.
- Range: 0 -5
Measured: 18 months
5DT Lecture - remote assessment
Assessed by:
Lecture subtest from 5 digit test: time
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
5DT counting - remote assessment
Assessed by:
Counting subtest from 5 digit test: time
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
5DT Choosing - remote assessment
Assessed by:
Choosing subtest from 5 digit test: time
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
5DT Switching - remote assessment
Assessed by:
Switching subtest from 5 digit test: time
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
5DT Inhibition - remote assessment
Assessed by:
Inhibition subtest from 5 digit test: time
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
5DT Flexibility - remote assessment
Assessed by:
Flexibility subtest from 5 digit test: time
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
IEDEEDS - remote assessment
IED EDS Errors: The number of times that the subject failed to select the stimulus compatible with the current rule on the stage where the extra-dimensional shift occurs. This is a measure of the subject's ability to shift attentional set.
Assessed by:
Intra-Extra Dimensional test from CANTAB battery.
- Raw score range: 0 - 50. Lower is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
IEDYERTA - remote assessment
IED Total Errors (Adjusted): The total number of times that the subject chose a wrong stimulus - i.e. one incompatible with the current rule, adjustment for every stage that was not reached. Lower is better. Total Errors Adjusted = Total Errors (problems reached) + [(number of unreached problems) * (25)] This is a measure of the subject's efficiency in attempting the test. Subjects failing at any stage of the test will have had less opportunity to make errors. The adjustment is carried out to compensate for this missing data, and provide a more comparable error score to subjects completing all stages of the test..
Assessed by:
Intra-Extra Dimensional test from CANTAB battery.
- Raw score range: 0 - 402. Lower is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
IEDYCOST - remote assessment
IED Stages Completed: This is the total number of stages the subject completed successfully. There are nine stages to be completed. Higher is better.
Assessed by:
Intra-Extra Dimensional test from CANTAB battery.
- Range: 0 - 9. Higher is better.
Measured: 18 months
SWM Total Errors - remote assessment
SWM Total Errors: The total number of times a box is selected that is certain not to contain a token and therefore should not have been visited by the subject, i.e. between errors + within errors - double errors. Calculated across all assessed four, six and eight token trials.
Assessed by:
Spatial Working Memory test from CANTAB battery.
- Range: 0 - 157. Lower is better
Measured: 18 months
SWM Between Errors - remote assessment
SWM Between Errors: The number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across all assessed four, six and eight token trials.
Assessed by:
Spatial Working Memory test from CANTAB battery:
- Raw score range: 0 - 153. Lower is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
SWM Within Errors - remote assessment
SWM Within Errors: The number of times a subject revisits a box already shown to be empty during the same search. Calculated across all assessed four, six and eight token trials.
Assessed by:
Spatial Working Memory test from CANTAB battery:
- Range: 0 - 153. Lower is better.
Measured: 18 months
SWM Double Errors - remote assessment
SWM Double Errors: The number of times a subject commits an error that is both a within error and a between error. Calculated across all assessed four, six and eight token trials.
Assessed by:
Spatial Working Memory test from CANTAB battery:
- Range: 0 - 147. Lower is better.
Measured: 18 months
SWMS - remote assessment
SWM Strategy (6-8 boxes): The number of times a subject begins a new search pattern from the same box they started with previously. If they always begin a search from the same starting point we infer that the subject is employing a planned strategy for finding the tokens. Therefore a low score indicates high strategy use (1 = they always begin the search from the same box), a high score indicates that they are beginning their searches from many different boxes. Calculated across assessed trials with 6 tokens or 8 tokens.
Assessed by:
Spatial Working Memory test from CANTAB battery:
- Range: 2 - 14. Lower is better.
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased
Measured: 18 months
SWMSX - remote assessment
SWM Strategy (6-12 boxes): The number of times a subject begins a new search pattern from the same box they started with previously. If they always begin a search from the same starting point we infer that the subject is employing a planned strategy for finding the tokens. Therefore a low score indicates high strategy use (1 = they always begin the search from the same box), a high score indicates that they are beginning their searches from many different boxes. Calculated across assessed trials with 6 tokens or more.
Assessed by:
Spatial Working Memory test from CANTAB battery:
- Range: 3 - 26. Lower is better.
Measured: 18 months
SWMPR - remote assessment
SWM Problem Reached: This measure reports the problem number that the subject reached, but did not necessarily complete.
Assessed by:
Spatial Working Memory test from CANTAB battery:
- Range: 2 - 6. Higher is better.
Measured: 18 months
ERTTH - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total Hits: The total number of times the subject selected the correct emotion. Calculated across all assessed trials.
- Range: 0 - 90. Higher is Better
Measured: 18 months
ERTTHH - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total Hits Happiness: The total number of times the subject correctly selected the emotion 'Happiness'. Calculated across all assessed trials.
- Range: 0 - 15 . Higher is Better
Measured: 18 months
ERTTHS - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total Hits Sadness: The total number of times the subject correctly selected the emotion 'Sadness'. Calculated across all assessed trials.
- Range: 0 - 15 . Higher is Better
Measured: 18 months
ERTTHF - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total Hits Fear: The total number of times the subject correctly selected the emotion 'Fear'. Calculated across all assessed trials.
- Range: 0 - 15 . Higher is Better
Measured: 18 months
ERTTHA - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total Hits Anger: The total number of times the subject correctly selected the emotion 'Anger'. Calculated across all assessed trials.
- Range: 0 - 15 . Higher is Better
Measured: 18 months
ERTTHSU - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery
ERT Total Hits Surprise: The total number of times the subject correctly selected the emotion 'Surprise'. Calculated across all assessed trials.
- Range: 0 - 15 . Higher is Better.
Measured: 18 months
ERTTHD - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total Hits Disgust: The total number of times the subject correctly selected the emotion 'Disgust'. Calculated across all assessed trials.
- Range: 0 - 15 . Higher is Better.
Measured: 18 months
ERTTFAH - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total False Alarms Happiness: The total number of times the subject incorrectly selected the emotion 'Happiness'. Calculated across all assessed trials.
- Range: 0 - 75 . Lower is Better.
Measured: 18 months
ERTTFAS - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total False Alarms Sadness: The total number of times the subject incorrectly selected the emotion 'Sadness'. Calculated across all assessed trials.
- Range: 0 - 75 . Lower is Better.
Measured: 18 months
ERTTFAF - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total False Alarms Fear: The total number of times the subject incorrectly selected the emotion 'Fear'. Calculated across all assessed trials.
- Range: 0 - 75 . Lower is Better.
Measured: 18 months
ERTTFAA - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total False Alarms Anger: The total number of times the subject incorrectly selected the emotion 'Anger'. Calculated across all assessed trials.
- Range: 0 - 75 . Lower is Better.
Measured: 18 months
ERTTFASU - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total False Alarms Surprise: The total number of times the subject incorrectly selected the emotion 'Surprise'. Calculated across all assessed trials.
- Range: 0 - 75 . Lower is Better.
Measured: 18 months
ERTTFAD - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Total False Alarms Disgust: The total number of times the subject incorrectly selected the emotion 'Disgust'. Calculated across all assessed trials.
- Range: 0 - 75 . Lower is Better.
Measured: 18 months
ERTUHRH - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Unbiased Hit Rate Happiness: The unbiased hit rate ensures that recognition accuracy of the Happiness emotion is not influenced by response guessing or response bias effects. It takes into consideration the joint probability of an individual making a correct response, based on the presentation of the correct stimulus out of the available possibilities. Calculated for assessed Happiness trials only.
- Range: 0 to 1. Higher is better.
Measured: 18 months
ERTUHRS - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Unbiased Hit Rate Sadness: The unbiased hit rate ensures that recognition accuracy of the Sadness emotion is not influenced by response guessing or response bias effects. It takes into consideration the joint probability of an individual making a correct response, based on the presentation of the correct stimulus out of the available possibilities. Calculated for assessed Sadness trials only
- Range: 0 to 1. Higher is better.
Measured: 18 months
ERTUHRF - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Unbiased Hit Rate Fear: The unbiased hit rate ensures that recognition accuracy of the Fear emotion is not influenced by response guessing or response bias effects. It takes into consideration the joint probability of an individual making a correct response, based on the presentation of the correct stimulus out of the available possibilities. Calculated for assessed Fear trials only.
- Range: 0 to 1. Higher is better.
Measured: 18 months
ERTUHRA - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Unbiased Hit Rate Anger: The unbiased hit rate ensures that recognition accuracy of the Anger emotion is not influenced by response guessing or response bias effects. It takes into consideration the joint probability of an individual making a correct response, based on the presentation of the correct stimulus out of the available possibilities. Calculated for assessed Anger trials only.
- Range: 0 to 1. Higher is better.
Measured: 18 months
ERTUHRSU - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Unbiased Hit Rate Surprise: The unbiased hit rate ensures that recognition accuracy of the Surprise emotion is not influenced by response guessing or response bias effects. It takes into consideration the joint probability of an individual making a correct response, based on the presentation of the correct stimulus out of the available possibilities. Calculated for assessed Anger trials only.
- Range: 0 to 1. Higher is better.
Measured: 18 months
ERTUHRSD - remote assessment
Assessed by:
Emotion Recognition Task from CANTAB battery.
ERT Unbiased Hit Rate Disgust: The unbiased hit rate ensures that recognition accuracy of the Disgust emotion is not influenced by response guessing or response bias effects. It takes into consideration the joint probability of an individual making a correct response, based on the presentation of the correct stimulus out of the available possibilities. Calculated for assessed Disgust trials only.
- Range: 0 to 1. Higher is better.
Measured: 18 months
Semantic fluency - remote assessment
Assessed by:
Semantic fluency test:
- Produce names of fruits and vegetables in 1 minute (Test Barcelona - Revised) (for ADULTS)
- Number of name of animals recalled in 1 minute + number of name of food and drinks recalled in 1 minute: from 0 to infinity (NEPSY - II) (for CHILDREN)
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Phonemic fluency - remote assessment
Assessed by:
Phonemic fluenct test:
- Produce words that start with letter M in 1 minute: range from 0 to infinity (Test Barcelona - Revised) (for ADULTS)
- Number of words started by letter "P" recalled in 1 minute + number of words started by letter "M" in 1 minute: range: from 0 to infinity (NEPSY-II) (for CHILDREN).
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Naming - remote assessment
Assessed by:
Boston Naming Test (BNT):
- Range: from 0 to 60
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Naming with cues - remote assessment
Assessed by: Boston Naming Test (BNT)
- Total correct with phonemic cue: from 0 to 60
Measured: 18 months
Time in Naming - remote assessment
Assessed by: Boston Naming Test (BNT): time to complete
Measured: 18 months
Visuospatial skills - remote assessment
Assessed by:
Benton Judgment of Line Orientation Test (JLO):
- Range: 0 to 30
Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Measured: 18 months
Psychiatric symptoms/disorders in remote assessments
Number of participants with psychiatric symptoms/disorders following DSM-IV-TR guidelines (psychotic symptoms, symptoms of depression, symptoms of mania, global functioning).
Measured: 18 months
Serial bias in working memory
This is quantified from the participant responses in the working memory task. Errors in the report of memorized locations are multiplied by the sign of the difference in locations in the previous and current trials and then averaged over the whole session to obtain the index of serial bias. We expect increases in this index as patients improve clinically.
Measured: 18 months
EEG reactivations in working memory
This is quantified by training decoders of memorized locations on EEG signals acquired over several electrodes during the working memory task. Reactivations are the average strength of the decoders during the fixation period of the next trial. We expect that EEG reactivations increase as patients improve clinically and correlate with the serial bias index.
Measured: 18 months
Slow-wave rate of growth during slow-wave sleep period
This is quantified from EEG recorded during sleep, by detecting individual slow-waves and estimating their strength, and then computing the rate of growth of this strength in the first slow-wave periods in the night. We expect the rate of growth of slow waves to increase as patients improve.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start16 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anti-NMDA Receptor EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Responsible party
- Sponsor
- Investigators
- Josep Dalmau, MD, PhD, Principal investigator, Hospital Clínic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183788
- Sponsor's protocol ID
- HR22-00221
- Acronym
- AMENDS
- Status last verified
- May 2024
- First submitted
- 19 May 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guasp M, Rosa-Justicia M, Munoz-Lopetegi A, Martinez-Hernandez E, Armangue T, Sugranyes G, Stein H, Borras R, Prades L, Arino H, Planaguma J, De-La-Serna E, Escudero D, Llufriu S, Sanchez-Valle R, Santamaria J, Compte A, Castro-Fornieles J, Dalmau J; Spanish anti-NMDAR Encephalitis Study Group. Clinical characterisation of patients in the post-acute stage of anti-NMDA receptor encephalitis: a prospective cohort study and comparison with patients with schizophrenia spectrum disorders. Lancet Neurol. 2022 Oct;21(10):899-910. doi: 10.1016/S1474-4422(22)00299-X.
PubMed 36115362Titulaer MJ, McCracken L, Gabilondo I, Armangue T, Glaser C, Iizuka T, Honig LS, Benseler SM, Kawachi I, Martinez-Hernandez E, Aguilar E, Gresa-Arribas N, Ryan-Florance N, Torrents A, Saiz A, Rosenfeld MR, Balice-Gordon R, Graus F, Dalmau J. Treatment and prognostic factors for long-term outcome in patients with anti-NMDA receptor encephalitis: an observational cohort study. Lancet Neurol. 2013 Feb;12(2):157-65. doi: 10.1016/S1474-4422(12)70310-1. Epub 2013 Jan 3.
PubMed 23290630Arino H, Munoz-Lopetegi A, Martinez-Hernandez E, Armangue T, Rosa-Justicia M, Escudero D, Matos N, Graus F, Sugranyes G, Castro-Fornieles J, Compte A, Dalmau J, Santamaria J. Sleep disorders in anti-NMDAR encephalitis. Neurology. 2020 Aug 11;95(6):e671-e684. doi: 10.1212/WNL.0000000000009987. Epub 2020 Jun 23.
PubMed 32576635Finke C, Kopp UA, Scheel M, Pech LM, Soemmer C, Schlichting J, Leypoldt F, Brandt AU, Wuerfel J, Probst C, Ploner CJ, Pruss H, Paul F. Functional and structural brain changes in anti-N-methyl-D-aspartate receptor encephalitis. Ann Neurol. 2013 Aug;74(2):284-96. doi: 10.1002/ana.23932. Epub 2013 Jul 8.
PubMed 23686722Heine J, Kopp UA, Klag J, Ploner CJ, Pruss H, Finke C. Long-Term Cognitive Outcome in Anti-N-Methyl-D-Aspartate Receptor Encephalitis. Ann Neurol. 2021 Dec;90(6):949-961. doi: 10.1002/ana.26241. Epub 2021 Oct 21.
PubMed 34595771Armangue T, Titulaer MJ, Malaga I, Bataller L, Gabilondo I, Graus F, Dalmau J; Spanish Anti-N-methyl-D-Aspartate Receptor (NMDAR) Encephalitis Work Group. Pediatric anti-N-methyl-D-aspartate receptor encephalitis-clinical analysis and novel findings in a series of 20 patients. J Pediatr. 2013 Apr;162(4):850-856.e2. doi: 10.1016/j.jpeds.2012.10.011. Epub 2012 Nov 16.
PubMed 23164315
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody-mediated NMDA Receptor Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Prolonged Recovery Stage
- ClinicalTrials.gov ID
- NCT06183788
- Acronym / sponsor ID
- AMENDS / HR22-00221
- Conditions
- Anti-NMDA Receptor Encephalitis
- Keywords
- Cognitive Impairment, Encephalitis, Autoimmune, Cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The encephalitis mediated by antibodies against the NMDA receptor (NMDARe) predominantly affects young adults and children resulting in severe neurologic and psychiatric deficits. After overcoming the acute stage, patients are left with long-lasting behavioral, cognitive, and psychiatric alterations with important socio-family-economical implications. Here investigators postulate that a better knowledge of this stage will improve treatment decisions and outcome.
In Aim 1, the post-acute stage will be clinically characterized, tools to remotely follow cognitive, behavioral and psychiatric deficits will be provided, and the impact of cognitive rehabilitation will be assessed.
In Aim 2, biomarkers (autoimmune, inflammatory, neuronal injury) will be identified as signatures of the acute and post-acute stages.
In Aim 3, a mouse model of NMDARe will be used to determine the underlying mechanisms and treatment of the postacute stage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-NMDARe patients with remote cognitive rehabilitation | Experimental | Behavioral: Remote cognitive rehabilitation programParticipants of a prospective cohort in post-acute phase of the Antibody-mediated NMDA Receptor Encephalitis that will received a behavioral treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥12 years old with NMDARe in the post-acute stage of the disease;
- ≤6 months from hospital discharge (acute phase)
Key exclusion criteria (2 listed)
- Inability to obtain informed consent;
- inability to travel to the center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote cognitive rehabilitation programRemote cognitive rehabilitation program will be performed through an online validated platform (Guttmann NeuroPersonalTrainer: https://gnpt.es/) run by the psychologists team. This is a Sanitary Product with CE certification (Sanitary Product RPS/430/2014; International Patent [PCT/ES2008/00677]) and here will be used within its approved indications. The rehabilitation program will increase in difficulty and decrease in frequency during the first year of follow-up (V1-V3). | Behavioural | Anti-NMDARe patients with remote cognitive rehabilitation |
Primary outcome
Age
Time frame: 18 months
Age measured in years
Gender
Time frame: 18 months
Male or female
Vision condition
Time frame: 18 months
Studied by optometer
Handedness
Time frame: 18 months
Right- or Left-handed
General medical history
Time frame: 18 months
Description of the most important issues compiled in the general medical history of the participant
Allergies
Time frame: 18 months
List of allergies of each participant
Symptoms related to NMDARe
Time frame: 18 months
Detailed description of symptoms experienced before, during and after the post-acute phase of NMDARe.
Treatments
Time frame: 18 months
All treatments in which the participant is being involved.
Functional status
Time frame: 18 months
Functional status according to Modified Rankin Scale (mRS) Modified Rankin Scale: - Range: from 0 points (no symptoms) to 6 points (dead).
Intelligence Quotient
Time frame: 18 months
Estimated through General Ability Index (GAI; from Weschler Adult Intelligence Scale - IV (WAIS-IV). This index is obtained through Verbal Comprehension Index (VCI) and Perceptual Reasoning Index (PRI). * Range of GAI: from 40 to 160. Higher is better. * Range of VCI: from 50 to 150. Higher is better. * Range of PRI: from 50 to 150. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Verbal working memory
Time frame: 18 months
Verbal Working Memory: Working Memory Index (WMI) from WAIS-IV. - Range of WMI: from 50 to 150. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Phonological loop
Time frame: 18 months
Assessed by Forward order span of Digit span subtest from WAIS-IV. - Range: from 0 to 9 Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Visual working memory
Time frame: 18 months
Visual Working Memory: Spatial location subtest from Weschler Memory Scale - IV (WMS-IV). - Range of Spatial Location subtest: from 0 to 32. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Verbal learning
Time frame: 18 months
Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) - Total learning: range: from 0 to 80. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Proactive interference verbal memory
Time frame: 18 months
Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) - Interference list: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Short-term verbal memory
Time frame: 18 months
Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) - Short-term memory free recall: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Long-term verbal memory
Time frame: 18 months
Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) - Long-term memory free recall: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Verbal recognition memory
Time frame: 18 months
Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) - Word-list Recognition: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Verbal discrimination memory
Time frame: 18 months
Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) - Discrimination index of word-list: False positives + omissions of recognition between 44 total words to recognize. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Verbal retention memory
Time frame: 18 months
Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) - Retention index: percentatge of Long-term memory free recall between Short-term memory free recall. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Immediate visual memory
Time frame: 18 months
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) - Immediate visual memory: range: from 0 to 36. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Delayed visual memory
Time frame: 18 months
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) - Delayed visual memory: range: from 0 to 12. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Visual retention memory
Time frame: 18 months
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) - Retention index: percentatge of Long-term memory free recall between the Higher punctuation at Trial 2 or 3. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Visual recognition memory
Time frame: 18 months
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) - Figure Recognition: range: from 0 to 6. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Visual discrimination memory
Time frame: 18 months
Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) - Discrimination index: figure recognized minus false positives. Range: from -6 to 6. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Processing speed
Time frame: 18 months
Processing speed Index (PSI; from Weschler Adult Intelligence Scale - IV (WAIS-IV). Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
TMT-A
Time frame: 18 months
Trail Making Test part A (TMT-A): - Time in seconds: from 0 to infinity. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
TMT-B
Time frame: 18 months
Trail Making Test part B (TMT-B): - Time in seconds: from 0 to infinity. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Naming
Time frame: 18 months
Assessed by: Boston Naming Test (BNT) - Total correct: from 0 to 60 Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Naming with cues
Time frame: 18 months
Assessed by: Boston Naming Test (BNT) - Total correct with phonemic cue: from 0 to 60
Latency in naming
Time frame: 18 months
Assessed by: Boston Naming Test (BNT) - Time to complete test in seconds
Semantic fluency
Time frame: 18 months
Number of name of animals recalled in 1 minute: range: from 0 to infinity. (Test Barcelona - Revised) (for ADULTS) Number of name of animals recalled in 1 minute + number of name of food and drinks recalled in 1 minute: from 0 to infinity (NEPSY - II) (for CHILDREN) Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Phonemic fluency
Time frame: 18 months
Number of words started by letter "M" recalled in 1 minute: Range: from 0 to infinity. (Test Barcelona-Revised) (for ADULTS) Number of words started by letter "P" recalled in 1 minute + number of words started by letter "M" in 1 minute: range: from 0 to infinity (NEPSY-II) (for CHILDREN). Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Visuospatial skills
Time frame: 18 months
Number location subtest of the Visual-Object Spatial and Perceptual battery. - Range: from 0 to 10 Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Visuospatial skills - children
Time frame: 18 months
Assessed by Arrows subtest of NEPSY-2 battery - Range: from 0 to 20 Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Stroop test - word subtest
Time frame: 18 months
- Words: words read in 45 seconds Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Stroop test - color subtest
Time frame: 18 months
- Colour: colours distinguished in 45 seconds. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Stroop test - word-color subtest
Time frame: 18 months
- Word-colour: colours distinguished in 45 seconds. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Detectability - CPT3
Time frame: 18 months
Assessed by Continuous Performance Test - 3rd Version. Measures the respondent's ability to differentiate non-targets (i.e. the letter X) from targets (i.e. all other letters). Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Omissions - CPT3
Time frame: 18 months
Assessed by Continuous Performance Test - 3rd Version. Result from a failure to respond to targets. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Comissions - CPT3
Time frame: 18 months
Assessed by Continuous Performance Test - 3rd Version. Comissions are made when responses are given to non-targets. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
HRT - CPT3
Time frame: 18 months
Assessed by Continuous Performance Test - 3rd Version. Hit Reaction Time (HRT) is the mean response speed of correct responses from the whole administration. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
HRT-SD - CPT3
Time frame: 18 months
Assessed by Continuous Performance Test - 3rd Version. Hit Reaction Time Standard Deviation (HRT-SD) is a measure of response speed consistency during the entire administration. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Variability- CPT3
Time frame: 18 months
Assessed by Continuous Performance Test - 3rd Version. The amount of variability that the patient showed in 18 separate segments of the administration in relation to their own overall Hit Reaction Time Standard Deviation (HRT-SD). It is a measure of response consistency and a "within respondent" measure". Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
HRT Block Change - CPT3
Time frame: 18 months
Assessed by Continuous Performance Test - 3rd Version. Hit Reaction Time Block Change indicates the change in mean response speed across blocks. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
HRT ISI Change - CPT3
Time frame: 18 months
Assessed by Continuous Performance Test - 3rd Version. Hit Reaction Time Inter-Stimulus Interval Change (HRT ISI Change) indicates the change in mean response speed at various ISIs. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation [SD] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased.
Prensence of psychiatric symptoms or disorders in presential assessments
Time frame: 18 months
Number of participants with psychiatric symptoms/disorders following DSM-IV-TR guidelines (psychotic symptoms, symptoms of depression, symptoms of mania, global functioning).
Sleep microstructure - Total study time
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Total sleep time: minutes
Sleep microstructure - Total sleep time
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Total sleep time: minutes
Sleep microstructure - Sleep efficiency
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Sleep efficiency: based on total study time and total sleep time
Sleep microstructure - Time to sleep onset
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Time to sleep onset: minutes
Sleep microstructure - Time in stage N1
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Time in stage N1: minutes
Sleep microstructure - Time in stage N2
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Time in stage N2: minutes
Sleep microstructure - Time in stage N3
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Time in stage N3: minutes
Sleep microstructure - Time in stage R
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Time in stage R: minutes
Sleep microstructure - First epoch of N1
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - First epoch of N1: minutes
Sleep microstructure - First epoch of N2
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - First epoch of N2: minutes
Sleep microstructure - First epoch of N3
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - First epoch of N3: minutes
Sleep microstructure - First epoch of REM
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - First epoch of REM: minutes
Sleep microstructure - REM/NREM time ratio
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - REM/NREM time ratio
Sleep microstructure - Number of arousals
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Number of arousals (total)
Sleep microstructure - Arousal Index
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Arousal Index
Sleep microstructure - Confusional arousals
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Confusional arousals: Yes or No
Sleep microstructure - Direct transition from N3 to W
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Direct transition from N3 to W: yes or no
Sleep microstructure - Delta arousals
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - "Delta arousals"?: yes, no or unknown
Sleep microstructure - Wake after sleep
Time frame: 18 months
It will be adapted to patient's sleep habits (~23:00 to 07:30) using a digital polygraph (Deltamed). This includes EEG in 43 scalp channels + 11 channels for electrooculography, electrocardiography, electromyography, and audiovisual recording (sampling rate 256 Hz). Sleep stages will be scored manually (AASM criteria) using 30-s epochs, with modifications depending on sleep alterations, as reported. Parameters: - Wake after sleep: hour
Adherence to cognitive treatment - 6 months
Time frame: 6 months
Number of sessions performed in 6 months
Adherence to cognitive treatment - 9 months
Time frame: 9 months
Number of sessions performed in 9 months
Adherence to cognitive treatment - 12 months
Time frame: 12 months
Number of sessions performed in 12 months
83 secondary outcomes
Immune/inflammatory signaling-target gene expression pathways
Time frame: 18 months
Neurofilament light chain (NfL) levels in acute stage
Time frame: 18 months
Neurofilament light chain (NfL) levels in post-acute stage
Time frame: 18 months
Cell immunophenotyping - proportion of CD4
Time frame: 18 months
Cell immunophenotyping - proportion of CD8
Time frame: 18 months
Cell immunophenotyping - proportion of CD8+CD45RA+
Time frame: 18 months
Cell immunophenotyping - proportion of CD8+CD45RO+
Time frame: 18 months
Cell immunophenotyping - proportion of iNKT
Time frame: 18 months
Cell immunophenotyping - proportion of CD19
Time frame: 18 months
Cell immunophenotyping - proportion of B naive (IgM+IgD+CD27-)
Time frame: 18 months
Cell immunophenotyping - proportion of B memory (IgD-)
Time frame: 18 months
Cell immunophenotyping - proportion of regulatory B cells
Time frame: 18 months
Cell immunophenotyping - proportion of plasmablasts
Time frame: 18 months
Cell immunophenotyping - proportion of NK cells
Time frame: 18 months
MRI
Time frame: 18 months
EEG: normalcy
Time frame: 18 months
EEG: time awake
Time frame: 18 months
EEG: time in drowsiness
Time frame: 18 months
EEG: time asleep
Time frame: 18 months
EEG: epileptiform activity
Time frame: 18 months
EEG: seizures
Time frame: 18 months
EEG: slowing
Time frame: 18 months
EEG: Changes with Intermittent Light Stimulation
Time frame: 18 months
EEG: Changes with hyperventilation
Time frame: 18 months
Verbal working memory - remote assessment
Time frame: 18 months
Verbal learning - remote assessment
Time frame: 18 months
Proactive interference verbal memory - remote assessment
Time frame: 18 months
Short-term verbal memory - remote assessment
Time frame: 18 months
Long-term verbal memory - remote assessment
Time frame: 18 months
Verbal recognition memory - remote assessment
Time frame: 18 months
Verbal discrimination memory - remote assessment
Time frame: 18 months
Complex figure copy - remote assessment
Time frame: 18 months
Time - Complex figure copy - remote assessment
Time frame: 18 months
Type - Complex figure copy - remote assessment
Time frame: 18 months
Short-term visual memory - remote assessment
Time frame: 18 months
Long-term visual memory - remote assessment
Time frame: 18 months
Orientation in time - remote assessment
Time frame: 18 months
Orientation in space - remote assessment
Time frame: 18 months
5DT Lecture - remote assessment
Time frame: 18 months
5DT counting - remote assessment
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 36115362Guasp M, Rosa-Justicia M, Munoz-Lopetegi A, Martinez-Hernandez E, Armangue T, Sugranyes G, Stein H, Borras R, Prades L, Arino H, Planaguma J, De-La-Serna E, Escudero D, Llufriu S, Sanchez-Valle R, Santamaria J, Compte A, Castro-Fornieles J, Dalmau J; Spanish anti-NMDAR Encephalitis Study Group. Clinical characterisation of patients in the post-acute stage of anti-NMDA receptor encephalitis: a prospective cohort study and comparison with patients with schizophrenia spectrum disorders. Lancet Neurol. 2022 Oct;21(10):899-910. doi: 10.1016/S1474-4422(22)00299-X.
- Background: PubMed 23290630Titulaer MJ, McCracken L, Gabilondo I, Armangue T, Glaser C, Iizuka T, Honig LS, Benseler SM, Kawachi I, Martinez-Hernandez E, Aguilar E, Gresa-Arribas N, Ryan-Florance N, Torrents A, Saiz A, Rosenfeld MR, Balice-Gordon R, Graus F, Dalmau J. Treatment and prognostic factors for long-term outcome in patients with anti-NMDA receptor encephalitis: an observational cohort study. Lancet Neurol. 2013 Feb;12(2):157-65. doi: 10.1016/S1474-4422(12)70310-1. Epub 2013 Jan 3.
- Background: PubMed 32576635Arino H, Munoz-Lopetegi A, Martinez-Hernandez E, Armangue T, Rosa-Justicia M, Escudero D, Matos N, Graus F, Sugranyes G, Castro-Fornieles J, Compte A, Dalmau J, Santamaria J. Sleep disorders in anti-NMDAR encephalitis. Neurology. 2020 Aug 11;95(6):e671-e684. doi: 10.1212/WNL.0000000000009987. Epub 2020 Jun 23.
- Background: PubMed 23686722Finke C, Kopp UA, Scheel M, Pech LM, Soemmer C, Schlichting J, Leypoldt F, Brandt AU, Wuerfel J, Probst C, Ploner CJ, Pruss H, Paul F. Functional and structural brain changes in anti-N-methyl-D-aspartate receptor encephalitis. Ann Neurol. 2013 Aug;74(2):284-96. doi: 10.1002/ana.23932. Epub 2013 Jul 8.
- Background: PubMed 34595771Heine J, Kopp UA, Klag J, Ploner CJ, Pruss H, Finke C. Long-Term Cognitive Outcome in Anti-N-Methyl-D-Aspartate Receptor Encephalitis. Ann Neurol. 2021 Dec;90(6):949-961. doi: 10.1002/ana.26241. Epub 2021 Oct 21.
- Background: PubMed 23164315Armangue T, Titulaer MJ, Malaga I, Bataller L, Gabilondo I, Graus F, Dalmau J; Spanish Anti-N-methyl-D-Aspartate Receptor (NMDAR) Encephalitis Work Group. Pediatric anti-N-methyl-D-aspartate receptor encephalitis-clinical analysis and novel findings in a series of 20 patients. J Pediatr. 2013 Apr;162(4):850-856.e2. doi: 10.1016/j.jpeds.2012.10.011. Epub 2012 Nov 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Dalmau, MD, PhD principal investigator
Hospital Clínic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote cognitive rehabilitation program in people with Anti-NMDA Receptor Encephalitis, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josep Dalmau, MD,PhD (34 93 227 1738, jdalmau@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: 18 months). The study lists 69 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06183788, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.