Social Cognition in Patients With Amyotrophic Lateral Sclerosis (COSISLA)
Primary Purpose
Social Cognition
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
neuropsychological test
Sponsored by
About this trial
This is an interventional other trial for Social Cognition
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- CHU AngersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients Amyotrophic Lateral Sclerosis
Control subjects
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04406675
First Posted
May 13, 2020
Last Updated
January 4, 2021
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT04406675
Brief Title
Social Cognition in Patients With Amyotrophic Lateral Sclerosis
Acronym
COSISLA
Official Title
Social Cognition in Patients With Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Cognition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients Amyotrophic Lateral Sclerosis
Arm Type
Other
Arm Title
Control subjects
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
neuropsychological test
Intervention Description
neuropsychological test
Primary Outcome Measure Information:
Title
Evaluate the social cognition capacities
Description
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.
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassereau Julien
Phone
0241355615
Email
jucassereau@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Muller Jeanne
Email
jeanne.muller@chu-angers.fr
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muller Jeanne
12. IPD Sharing Statement
Learn more about this trial
Social Cognition in Patients With Amyotrophic Lateral Sclerosis
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