Social Cognition in Patients With Amyotrophic Lateral Sclerosis

Social Cognition Clinical Trial

— COSISLA  

Official title:

Social Cognition in Patients With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406675
• Other study ID #: 2020-A01213-36
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: September 2023

Study information

• Verified date: June 2020
• Source: University Hospital, Angers
• Contact: Cassereau Julien
• Phone: 0241355615
• Email: jucassereau[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Social Cognition

Intervention

Other:
• neuropsychological test
neuropsychological test

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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