Social Cognition in Patients With Amyotrophic Lateral Sclerosis
COSISLA
1 other identifier
interventional
58
1 country
1
Brief Summary
Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. The clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower motor neuron signs and symptoms. The most recent studies suggest that up to 50% of Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance. Impaired social cognition, including a deficit in the recognition of facial emotions and the identification of vocal prosody, is recognized as a part of the cognitive phenotype of Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers' training. However, studies remain scarce and the data acquired must be supported. The evolution of these manifestations during the disease is still poorly understood. In this study the investigators aim to assess the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2026
CompletedJune 4, 2026
June 1, 2026
5.7 years
May 13, 2020
June 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the social cognition capacities
Evaluate the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to control subjects using dynamic social cognition tests : Movie for the Assessment of Social Cognition. The maximum score is 48 points. The higher the score for correct answers, the better the performance.
One day
Study Arms (2)
Patients Amyotrophic Lateral Sclerosis
OTHERControl subjects
OTHERInterventions
neuropsychological test
Eligibility Criteria
You may qualify if:
- Patient Amyotrophic Lateral Sclerosis :
- Education of at least 7 years
- Native language: French
- Patients Amyotrophic Lateral Sclerosis
- Signature of informed consent to participate in the study
- Accompanied patient
- Control subject :
- People without any pathology
- Education of at least 7 years
- Native language: French
- Signature of informed consent to participate in the study
You may not qualify if:
- Patient Amyotrophic Lateral Sclerosis and control subject :
- Simultaneous participation in another interventional protocol with experimental treatment
- Inability to perform cognitive study tests
- Pregnant, lactating or parturient women
- Persons deprived of their liberty by administrative or judicial decision
- Persons under psychiatric care under duress
- Persons subject to legal protection measures
- Persons out of state to express their consent
- People not affiliated or not beneficiaries of a social security scheme
- History likely to disturb cognition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Angers
Angers, Angers, 49933, France
Related Publications (1)
Faure-de Baets J, Besnard J, Cassereau J, Emmelin E, Allain P. Assessment of social cognition in patients with amyotrophic lateral sclerosis: protocol for a cross-sectional comparative study at Angers University Hospita. BMJ Open. 2025 Jul 5;15(7):e097543. doi: 10.1136/bmjopen-2024-097543.
PMID: 40617623DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 28, 2020
Study Start
September 21, 2020
Primary Completion
May 29, 2026
Study Completion
May 29, 2026
Last Updated
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer contract (data access agreement), for the duration indicated in the contract.
- Access Criteria
- The data will be made available via secure transfer (sharing platform validated by Angers CHU: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared later upon request (e.g., the CRF to allow a collaborator to select the data to which they wish to have access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the MIVAR investigator, based on a protocol provided by the applicant, after verification of obtaining regulatory authorizations, including the favorable opinion of an ethics committee.