Amyotrophic Lateral SclerosisNCT06566651
Emotion Processing Among Patients With ALS
An observational study of Amyotrophic Lateral Sclerosis and Neuromuscular Diseases, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The goal of this observational study is to learn about the emotional perception in people with ALS disease compared to people with other neuromuscular disease and healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases, ALS
- What is being tested?
- Emotion Discrimination Task (EDT)
- How many people
- 180 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Dec 2023to 30 Jun 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Residents of Aarhus and Aalborg * Patients at Aarhus University Hospital * Patients at Aalborg University Hospital
Who may be able to join
- ALS patients, ambulant and hospitalized
- Able to give informed consent
- Diagnosed with ALS or probable ALS according to the existing revision of the El Escorial Criteria 21,22.
- Patients with a peripheral neuromuscular disease, ambulant and hospitalized
- Able to give informed consent
- Diagnosed with a peripheral neuromuscular disease, that does not affect CNS, including but not limited to Myasthenia Gravis and polyneuropathy
Show all 9Show fewer
- Healthy controls
- Able to give informed consent
- Age and gender matched to ALS patients
Who cannot join
- All Participants
- Other severe medical, neurological, or psychiatric disorders
- Visual impairment to an extent that interferes with the ability to perform of the test
- Severe motor or cognitive deficits, to the extent that the test-task cannot be performed
- Alcohol or drug abuse to an extent the interferes with task performance
- Patients with a peripheral neuromuscular disease
Show all 10Show fewer
- ● Familial predisposition to ALS
- Healthy controls
- Familial predisposition to ALS (first degree relatives)
- Medical treatment that affects the central nervous system (e.g., antidepressants)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aalborg University Hospital
Aalborg, Region Nordjulland, 9000
Jakob U Blicher, Ph.D, 78469939, jbli@cfin.au.dk
- Recruiting
Aarhus University Hospital
Aarhus, Central Jutland, 8200
Mia B Heintzelmann, Cand.med, 78454255, minielse@rm.dk
About this study
Official title: Emotion and Interoception Processing in ALS
The goal of this observational study is to learn about the emotional perception in people with ALS disease compared to people with other neuromuscular disease and healthy controls. The main questions it aims to answer are:
- How people with ALS judge happy and angry faces and what their "insight" into these judgements are like
- How their autonomic responses differ from the other two test group Participants will asked to judge if a face presents a happy emotion or angry emotion.
Researchers will compare the ALS group responses with neuromuscular diseases group and healthy control group responses to see if the ALS group judge more happy faces than angry.
Read the detailed description
Mild cognitive and behavioral changes occur in 35% of ALS patients and 10-15% of patients meet the criteria for FTD1-4. Recent research suggests changes in emotional perception and social cognition are a part of the neuropsychological changes in ALS, possibly associated with cognitive and behavioral symptoms seen in ALS-FTD5-9.
The aim of this project is to investigate emotional perception in ALS patients compared to healthy controls and patients with other neuromuscular diseases that do not affect the central nervous system. We use a simple emotion discrimination task to evaluate emotional bias and metacognition of emotion discrimination. Moreover, this project aims to explore the correlation between emotion perception and autonomic reactivity in ALS patients by recording heart rate frequency and respiration frequency during the EDT.
The project will contribute with deeper insights to the neuropsychological changes in ALS patients and the opportunity to quantify these changes. Thereby, the project will add new perspectives to the discussion of how we evaluate socio-emotional aspects of ALS in both clinical decision-making, guidance of relatives and future research.
- Conditions
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases, ALS, Motor Neuron Disease, MND (Motor Neurone DIsease)
- Being tested
- Emotion Discrimination Task (EDT)
- Keywords
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases, Emotion Perception, Emotion Processing, Emotion Recognition, Autonomic Responses, Respiratory Responses, Heart rate, Emotion Discrimination Task, ALS, Motorneuron disease, MND
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Discrimination Task (EDT)Other
It estimates the subjective bias and sensitivity in discriminating between happy and angry facial expressions of different intensities of emotional expression
| Study group | Role | What they receive |
|---|---|---|
| Amyotrophic Lateral Sclerosis (ALS) | People diagnosed or suspected of having the neurodegenerative disease Amyotrophic Lateral Sclerosis (ALS) Receives: Other: Emotion Discrimination Task (EDT) | |
| Neuromuscular | People diagnosed with a neuromuscular disease other than ALS Receives: Other: Emotion Discrimination Task (EDT) | |
| Control | Healthy people Receives: Other: Emotion Discrimination Task (EDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The perception of facial emotions measured using an Emotion Discrimination Task (EDT).
The EDT requires subjects to assess the facial emotion of a face stimulus and report whether the facial emotion was angry or happy. This will be the operationalisation of subjects' emotion perception, which we anticipate will reveal a bias towards positive perceptions. There is thus two scores on this scale: "Angry" and "Happy". There is no one of these scores that is "better" than the other. It is an nominal categorical scare.
Measured: 20 minutes
Metacognitive sensitivity measured using a retrospective confidence rating scale
Metacognitive insight will be operationalized through a metacognitive sensitivity measure. The method employed for this is a confidence rating measure, where subjects assess their own performance on the EDT. Subjects will indicate on a sliding scale, ranging from "very confident" (maximum score) to a "pure guess" (minimum score), how confident they are that their previous answer was correct. Generally higher scores on this scale is considered better. This scales title is: " Confidence Rating Scale".
Measured: 20 minutes
Secondary outcomes (2)
Subjects' heart rate is monitored throughout the EDT
Subjects heart rate is measured through a standard 3-lead electrocardiogram montage. Electrodes were place on both collarbones and on the left lower rib.
Measured: 20 minutes
Subjects' respiration is monitored throughout the EDT
Subjects' respiration is measured using a respiratory belt around the upper torso.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start15 Dec 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital
- Responsible party
- Principal investigator, Mia Heintzelmann, University of Aarhus
- Investigators
- Mia B Heintzelmann, Cand.med, Principal investigator, Department of Neurology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566651
- Sponsor's protocol ID
- emotionperceptionALS11072308
- Status last verified
- Aug 2024
- First submitted
- 28 Nov 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD. Once the data is fully anonymized, they may be released on public scientific repositories such as Github or Figshare.
Publications
Swinnen B, Robberecht W. The phenotypic variability of amyotrophic lateral sclerosis. Nat Rev Neurol. 2014 Nov;10(11):661-70. doi: 10.1038/nrneurol.2014.184. Epub 2014 Oct 14.
PubMed 25311585Sedda A. Disorders of emotional processing in amyotrophic lateral sclerosis. Curr Opin Neurol. 2014 Dec;27(6):659-65. doi: 10.1097/WCO.0000000000000147.
PubMed 25333604Strong MJ, Abrahams S, Goldstein LH, Woolley S, Mclaughlin P, Snowden J, Mioshi E, Roberts-South A, Benatar M, HortobaGyi T, Rosenfeld J, Silani V, Ince PG, Turner MR. Amyotrophic lateral sclerosis - frontotemporal spectrum disorder (ALS-FTSD): Revised diagnostic criteria. Amyotroph Lateral Scler Frontotemporal Degener. 2017 May;18(3-4):153-174. doi: 10.1080/21678421.2016.1267768. Epub 2017 Jan 5.
PubMed 28054827Strong MJ, Yang W. The frontotemporal syndromes of ALS. Clinicopathological correlates. J Mol Neurosci. 2011 Nov;45(3):648-55. doi: 10.1007/s12031-011-9609-0. Epub 2011 Aug 2.
PubMed 21809041Bora E. Meta-analysis of social cognition in amyotrophic lateral sclerosis. Cortex. 2017 Mar;88:1-7. doi: 10.1016/j.cortex.2016.11.012. Epub 2016 Dec 5.
PubMed 28002755Martins AP, Prado LGR, Lillo P, Mioshi E, Teixeira AL, de Souza LC. Deficits in Emotion Recognition as Markers of Frontal Behavioral Dysfunction in Amyotrophic Lateral Sclerosis. J Neuropsychiatry Clin Neurosci. 2019 Spring;31(2):165-169. doi: 10.1176/appi.neuropsych.18040086. Epub 2018 Dec 12.
PubMed 30537912Oh SI, Oh KW, Kim HJ, Park JS, Kim SH. Impaired Perception of Emotional Expression in Amyotrophic Lateral Sclerosis. J Clin Neurol. 2016 Jul;12(3):295-300. doi: 10.3988/jcn.2016.12.3.295. Epub 2016 Apr 19.
PubMed 27095526Zimmerman EK, Eslinger PJ, Simmons Z, Barrett AM. Emotional perception deficits in amyotrophic lateral sclerosis. Cogn Behav Neurol. 2007 Jun;20(2):79-82. doi: 10.1097/WNN.0b013e31804c700b.
PubMed 17558250Lule D, Kurt A, Jurgens R, Kassubek J, Diekmann V, Kraft E, Neumann N, Ludolph AC, Birbaumer N, Anders S. Emotional responding in amyotrophic lateral sclerosis. J Neurol. 2005 Dec;252(12):1517-24. doi: 10.1007/s00415-005-0907-8. Epub 2005 Jun 24.
PubMed 15977000Crespi C, Cerami C, Dodich A, Canessa N, Arpone M, Iannaccone S, Corbo M, Lunetta C, Scola E, Falini A, Cappa SF. Microstructural white matter correlates of emotion recognition impairment in Amyotrophic Lateral Sclerosis. Cortex. 2014 Apr;53:1-8. doi: 10.1016/j.cortex.2014.01.002. Epub 2014 Jan 18.
PubMed 24534360Lule D, Diekmann V, Anders S, Kassubek J, Kubler A, Ludolph AC, Birbaumer N. Brain responses to emotional stimuli in patients with amyotrophic lateral sclerosis (ALS). J Neurol. 2007 Apr;254(4):519-27. doi: 10.1007/s00415-006-0409-3. Epub 2007 Mar 31.
PubMed 17401515Aho-Ozhan HE, Keller J, Heimrath J, Uttner I, Kassubek J, Birbaumer N, Ludolph AC, Lule D. Perception of Emotional Facial Expressions in Amyotrophic Lateral Sclerosis (ALS) at Behavioural and Brain Metabolic Level. PLoS One. 2016 Oct 14;11(10):e0164655. doi: 10.1371/journal.pone.0164655. eCollection 2016.
PubMed 27741285Finegan E, Chipika RH, Li Hi Shing S, Hardiman O, Bede P. Pathological Crying and Laughing in Motor Neuron Disease: Pathobiology, Screening, Intervention. Front Neurol. 2019 Mar 21;10:260. doi: 10.3389/fneur.2019.00260. eCollection 2019.
PubMed 30949121Caga J, Hsieh S, Lillo P, Dudley K, Mioshi E. The Impact of Cognitive and Behavioral Symptoms on ALS Patients and Their Caregivers. Front Neurol. 2019 Mar 11;10:192. doi: 10.3389/fneur.2019.00192. eCollection 2019.
PubMed 30915018de Wit J, Bakker LA, van Groenestijn AC, van den Berg LH, Schroder CD, Visser-Meily JMA, Beelen A. Caregiver burden in amyotrophic lateral sclerosis: A systematic review. Palliat Med. 2018 Jan;32(1):231-245. doi: 10.1177/0269216317709965. Epub 2017 Jul 3.
PubMed 28671483
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion and Interoception Processing in ALS
- ClinicalTrials.gov ID
- NCT06566651
- Acronym / sponsor ID
- emotionperceptionALS11072308
- Conditions
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases, ALS, Motor Neuron Disease, MND (Motor Neurone DIsease)
- Keywords
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases, Emotion Perception, Emotion Processing, Emotion Recognition, Autonomic Responses, Respiratory Responses, Heart rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Aug 2024 (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 goal of this observational study is to learn about the emotional perception in people with ALS disease compared to people with other neuromuscular disease and healthy controls. The main questions it aims to answer are:
- How people with ALS judge happy and angry faces and what their "insight" into these judgements are like
- How their autonomic responses differ from the other two test group Participants will asked to judge if a face presents a happy emotion or angry emotion.
Researchers will compare the ALS group responses with neuromuscular diseases group and healthy control group responses to see if the ALS group judge more happy faces than angry.
Detailed description
Mild cognitive and behavioral changes occur in 35% of ALS patients and 10-15% of patients meet the criteria for FTD1-4. Recent research suggests changes in emotional perception and social cognition are a part of the neuropsychological changes in ALS, possibly associated with cognitive and behavioral symptoms seen in ALS-FTD5-9.
The aim of this project is to investigate emotional perception in ALS patients compared to healthy controls and patients with other neuromuscular diseases that do not affect the central nervous system. We use a simple emotion discrimination task to evaluate emotional bias and metacognition of emotion discrimination. Moreover, this project aims to explore the correlation between emotion perception and autonomic reactivity in ALS patients by recording heart rate frequency and respiration frequency during the EDT.
The project will contribute with deeper insights to the neuropsychological changes in ALS patients and the opportunity to quantify these changes. Thereby, the project will add new perspectives to the discussion of how we evaluate socio-emotional aspects of ALS in both clinical decision-making, guidance of relatives and future research.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amyotrophic Lateral Sclerosis (ALS) | – | Other: Emotion Discrimination Task (EDT)People diagnosed or suspected of having the neurodegenerative disease Amyotrophic Lateral Sclerosis (ALS) |
| Neuromuscular | – | Other: Emotion Discrimination Task (EDT)People diagnosed with a neuromuscular disease other than ALS |
| Control | – | Other: Emotion Discrimination Task (EDT)Healthy people |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Residents of Aarhus and Aalborg * Patients at Aarhus University Hospital * Patients at Aalborg University Hospital
Key inclusion criteria (9 listed)
- ALS patients, ambulant and hospitalized
- Patients with a peripheral neuromuscular disease, ambulant and hospitalized
- Healthy controls
Key exclusion criteria (10 listed)
- All Participants
- Patients with a peripheral neuromuscular disease
- ● Familial predisposition to ALS
- Healthy controls
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 |
|---|---|---|
| Emotion Discrimination Task (EDT)It estimates the subjective bias and sensitivity in discriminating between happy and angry facial expressions of different intensities of emotional expression | Other | Amyotrophic Lateral Sclerosis (ALS), Control, Neuromuscular |
Primary outcome
The perception of facial emotions measured using an Emotion Discrimination Task (EDT).
Time frame: 20 minutes
The EDT requires subjects to assess the facial emotion of a face stimulus and report whether the facial emotion was angry or happy. This will be the operationalisation of subjects' emotion perception, which we anticipate will reveal a bias towards positive perceptions. There is thus two scores on this scale: "Angry" and "Happy". There is no one of these scores that is "better" than the other. It is an nominal categorical scare.
Metacognitive sensitivity measured using a retrospective confidence rating scale
Time frame: 20 minutes
Metacognitive insight will be operationalized through a metacognitive sensitivity measure. The method employed for this is a confidence rating measure, where subjects assess their own performance on the EDT. Subjects will indicate on a sliding scale, ranging from "very confident" (maximum score) to a "pure guess" (minimum score), how confident they are that their previous answer was correct. Generally higher scores on this scale is considered better. This scales title is: " Confidence Rating Scale".
2 secondary outcomes
Subjects' heart rate is monitored throughout the EDT
Time frame: 20 minutes
Subjects' respiration is monitored throughout the EDT
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 25311585Swinnen B, Robberecht W. The phenotypic variability of amyotrophic lateral sclerosis. Nat Rev Neurol. 2014 Nov;10(11):661-70. doi: 10.1038/nrneurol.2014.184. Epub 2014 Oct 14.
- Background: PubMed 25333604Sedda A. Disorders of emotional processing in amyotrophic lateral sclerosis. Curr Opin Neurol. 2014 Dec;27(6):659-65. doi: 10.1097/WCO.0000000000000147.
- Background: PubMed 28054827Strong MJ, Abrahams S, Goldstein LH, Woolley S, Mclaughlin P, Snowden J, Mioshi E, Roberts-South A, Benatar M, HortobaGyi T, Rosenfeld J, Silani V, Ince PG, Turner MR. Amyotrophic lateral sclerosis - frontotemporal spectrum disorder (ALS-FTSD): Revised diagnostic criteria. Amyotroph Lateral Scler Frontotemporal Degener. 2017 May;18(3-4):153-174. doi: 10.1080/21678421.2016.1267768. Epub 2017 Jan 5.
- Background: PubMed 21809041Strong MJ, Yang W. The frontotemporal syndromes of ALS. Clinicopathological correlates. J Mol Neurosci. 2011 Nov;45(3):648-55. doi: 10.1007/s12031-011-9609-0. Epub 2011 Aug 2.
- Background: PubMed 28002755Bora E. Meta-analysis of social cognition in amyotrophic lateral sclerosis. Cortex. 2017 Mar;88:1-7. doi: 10.1016/j.cortex.2016.11.012. Epub 2016 Dec 5.
- Background: PubMed 30537912Martins AP, Prado LGR, Lillo P, Mioshi E, Teixeira AL, de Souza LC. Deficits in Emotion Recognition as Markers of Frontal Behavioral Dysfunction in Amyotrophic Lateral Sclerosis. J Neuropsychiatry Clin Neurosci. 2019 Spring;31(2):165-169. doi: 10.1176/appi.neuropsych.18040086. Epub 2018 Dec 12.
- Background: PubMed 27095526Oh SI, Oh KW, Kim HJ, Park JS, Kim SH. Impaired Perception of Emotional Expression in Amyotrophic Lateral Sclerosis. J Clin Neurol. 2016 Jul;12(3):295-300. doi: 10.3988/jcn.2016.12.3.295. Epub 2016 Apr 19.
- Background: PubMed 17558250Zimmerman EK, Eslinger PJ, Simmons Z, Barrett AM. Emotional perception deficits in amyotrophic lateral sclerosis. Cogn Behav Neurol. 2007 Jun;20(2):79-82. doi: 10.1097/WNN.0b013e31804c700b.
- Background: PubMed 15977000Lule D, Kurt A, Jurgens R, Kassubek J, Diekmann V, Kraft E, Neumann N, Ludolph AC, Birbaumer N, Anders S. Emotional responding in amyotrophic lateral sclerosis. J Neurol. 2005 Dec;252(12):1517-24. doi: 10.1007/s00415-005-0907-8. Epub 2005 Jun 24.
- Background: PubMed 24534360Crespi C, Cerami C, Dodich A, Canessa N, Arpone M, Iannaccone S, Corbo M, Lunetta C, Scola E, Falini A, Cappa SF. Microstructural white matter correlates of emotion recognition impairment in Amyotrophic Lateral Sclerosis. Cortex. 2014 Apr;53:1-8. doi: 10.1016/j.cortex.2014.01.002. Epub 2014 Jan 18.
- Background: PubMed 17401515Lule D, Diekmann V, Anders S, Kassubek J, Kubler A, Ludolph AC, Birbaumer N. Brain responses to emotional stimuli in patients with amyotrophic lateral sclerosis (ALS). J Neurol. 2007 Apr;254(4):519-27. doi: 10.1007/s00415-006-0409-3. Epub 2007 Mar 31.
- Background: PubMed 27741285Aho-Ozhan HE, Keller J, Heimrath J, Uttner I, Kassubek J, Birbaumer N, Ludolph AC, Lule D. Perception of Emotional Facial Expressions in Amyotrophic Lateral Sclerosis (ALS) at Behavioural and Brain Metabolic Level. PLoS One. 2016 Oct 14;11(10):e0164655. doi: 10.1371/journal.pone.0164655. eCollection 2016.
- Individual participant dataSharing planned: Yes. All collected IPD. Once the data is fully anonymized, they may be released on public scientific repositories such as Github or Figshare.
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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.
Mia B Heintzelmann, Cand.med principal investigator
Department of Neurology, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Neuromuscular Diseases, run by University of Aarhus at 2 sites in Denmark.
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 9 inclusion and 10 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 Mia B Heintzelmann, Cand.med (78454255, minielse@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The perception of facial emotions measured using an Emotion Discrimination Task (EDT). (time frame: 20 minutes). The study lists 2 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 NCT06566651, which also lists 22 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 22 Aug 2024.