Social Cognition in Patients With Amyotrophic Lateral Sclerosis

Not Applicable

• Conditions: Social Cognition
• Interventions: Other: neuropsychological test

• Registration Number: NCT04406675
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-28
• Status Verified: 2020-06
• Study Start: 2020-09-21
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-05
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control subjects	neuropsychological test	-
Patients Amyotrophic Lateral Sclerosis	neuropsychological test	-

Primary Outcome Measures

Name	Time	Method
Evaluate the social cognition capacities	One day	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.

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, France