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OpenTrials
Completed

NCT Number: NCT04406675

Social Cognition in Patients With Amyotrophic Lateral Sclerosis

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers

Angers, 49933, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neuropsychological test

Other

neuropsychological test

Primary outcomes

  1. Evaluate the social cognition capacities

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: COSISLA

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 28, 2020
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.