NMDAR Antibody-associated Auto-immune EncephalitisSAPIENCENCT05954468
Psycho-social Impact of Anti-NMDAR Encephalitis
An observational study of NMDAR Antibody-associated Auto-immune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
NMDA receptor encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms, but a typically good functional neurological outcome. The majority of patients experience long-term cognitive, psychological and social impairments that have significant consequences for their well-being and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NMDAR Antibody-associated Auto-immune Encephalitis
- What is being tested?
- standardized and validated surveys
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2023to 4 Sep 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study involves patients with autoimmune encephalitis with anti-NMDAR antibodies.
Who may be able to join
- Patients with anti-NMDAR encephalitis
- Year ≥ 18 ans
- Patients affiliated to the social security scheme
Who cannot join
- Patients with no anti-NMDAR encephalitis
- Minor patient
- Patient under guardianship or curatorship
- Patient with preexisting neurological symptoms
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Hôpital neurologique Pierre Wertheimer
Bron, Bron, 69500
About this study
NMDA receptor encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms, but a typically good functional neurological outcome. The majority of patients experience long-term cognitive, psychological and social impairments that have significant consequences for their well-being and quality of life. However, as the disease was only recently discovered (Dalmau and al. Annals of neurology, 2007), this psycho-social impact has not been studied systematically and the resulting consequences for patients are not adequately appreciated.
The proposed study aims at characterizing the cognitive and psycho-social long-term consequences of this rare disease. Our main hypothesis is that NMDAR encephalitis has a persistent and clinically relevant impact on the patients' long-term cognitive, psychological and social well-being. Furthermore, we hypothesize that longterm subjective outcomes depend on both internal and external factors, such as acute disease course, access to post-acute care, caregiver support, personal coping strategies, or access to health education resources and peer group support.
- Being tested
- standardized and validated surveys
- Keywords
- auto-immune encephalitis, NMDA receptor encephalitis, Health-related quality of life, psyco-social impact, cognitive consequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized and validated surveysOther
To evaluate the cognitive and psycho-social long term impact of a NMDAR encephalitis, we will collect the data using specific interview assessments such as the PROMS (Patient-reported Outcome Measures Information System) and PREMS (Patient-reported experiences measures) as well as we will check the cognitive performance in order to combine the expertise from clinical neurology, social \& health psychology
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive and psycho-social analyses of patients with NMDAR encephalitis.
The analyze will focus on the post-acute phase of the disease.
Measured: At study completion in an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start9 Oct 2023
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMDAR Antibody-associated Auto-immune EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954468
- Sponsor's protocol ID
- 69HCL21_0628
- Acronym
- SAPIENCE
- Status last verified
- Sep 2024
- First submitted
- 13 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psycho-social Impact of Anti-NMDAR Encephalitis
- ClinicalTrials.gov ID
- NCT05954468
- Acronym / sponsor ID
- SAPIENCE / 69HCL21_0628
- Keywords
- auto-immune encephalitis, NMDA receptor encephalitis, Health-related quality of life, psyco-social impact, cognitive consequence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 20 Jul 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.
NMDA receptor encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms, but a typically good functional neurological outcome. The majority of patients experience long-term cognitive, psychological and social impairments that have significant consequences for their well-being and quality of life. However, as the disease was only recently discovered (Dalmau and al. Annals of neurology, 2007), this psycho-social impact has not been studied systematically and the resulting consequences for patients are not adequately appreciated.
The proposed study aims at characterizing the cognitive and psycho-social long-term consequences of this rare disease. Our main hypothesis is that NMDAR encephalitis has a persistent and clinically relevant impact on the patients' long-term cognitive, psychological and social well-being. Furthermore, we hypothesize that longterm subjective outcomes depend on both internal and external factors, such as acute disease course, access to post-acute care, caregiver support, personal coping strategies, or access to health education resources and peer group support.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study involves patients with autoimmune encephalitis with anti-NMDAR antibodies.
Key inclusion criteria (3 listed)
- Patients with anti-NMDAR encephalitis
- Year ≥ 18 ans
- Patients affiliated to the social security scheme
Key exclusion criteria (4 listed)
- Patients with no anti-NMDAR encephalitis
- Minor patient
- Patient under guardianship or curatorship
- Patient with preexisting neurological symptoms
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 |
|---|---|---|
| standardized and validated surveysTo evaluate the cognitive and psycho-social long term impact of a NMDAR encephalitis, we will collect the data using specific interview assessments such as the PROMS (Patient-reported Outcome Measures Information System) and PREMS (Patient-reported experiences measures) as well as we will check the cognitive performance in order to combine the expertise from clinical neurology, social \& health psychology | Other | – |
Primary outcome
Cognitive and psycho-social analyses of patients with NMDAR encephalitis.
Time frame: At study completion in an average of 12 months
The analyze will focus on the post-acute phase of the disease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NMDAR Antibody-associated Auto-immune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Sep 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive and psycho-social analyses of patients with NMDAR encephalitis. (time frame: At study completion in an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.