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Social Cognition in Patients With Amyotrophic Lateral Sclerosis (COSISLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406675
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Social Cognition Other: neuropsychological test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Social Cognition in Patients With Amyotrophic Lateral Sclerosis
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023


Arm Intervention/treatment
Patients Amyotrophic Lateral Sclerosis Other: neuropsychological test
neuropsychological test

Control subjects Other: neuropsychological test
neuropsychological test




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406675


Contacts
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Contact: Cassereau Julien 0241355615 jucassereau@chu-angers.fr
Contact: Muller Jeanne jeanne.muller@chu-angers.fr

Locations
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France
CHU Angers Recruiting
Angers, France, 49933
Contact: Muller Jeanne         
Sponsors and Collaborators
University Hospital, Angers
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04406675    
Other Study ID Numbers: 2020-A01213-36
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases