NCT04406675

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2020Sep 2026

First Submitted

Initial submission to the registry

May 13, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

May 13, 2020

Last Update Submit

March 4, 2026

Conditions

Social Cognition

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients Amyotrophic Lateral Sclerosis

OTHER
Other: neuropsychological test

Control subjects

OTHER
Other: neuropsychological test

Interventions

neuropsychological testOTHER

neuropsychological test

Control subjectsPatients Amyotrophic Lateral Sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, Angers, 49933, France

RECRUITING

Related Publications (1)

  • Faure-de Baets J, Besnard J, Cassereau J, Emmelin E, Allain P. Assessment of social cognition in patients with amyotrophic lateral sclerosis: protocol for a cross-sectional comparative study at Angers University Hospita. BMJ Open. 2025 Jul 5;15(7):e097543. doi: 10.1136/bmjopen-2024-097543.

    PMID: 40617623DERIVED

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Cassereau Julien

CONTACT

0241355615jucassereau@chu-angers.fr

Muller Jeanne

CONTACT

jeanne.muller@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 28, 2020

Study Start

September 21, 2020

Primary Completion (Estimated)

September 21, 2026

Study Completion (Estimated)

September 21, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

FR(1)