Social Cognition in Patients With Amyotrophic Lateral Sclerosis (COSISLA)

University Hospital, Angers

Status: Unknown

Conditions: Social Cognition

Treatments: Other: neuropsychological test

Study type: Interventional

Funder types: Other

Identifiers

NCT04406675

2020-A01213-36

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Patients Amyotrophic Lateral Sclerosis

Other group

Treatment:

Other: neuropsychological test

Control subjects

Other group

Treatment:

Other: neuropsychological test