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METACOGSEP: Metacognition Assessment in Patient With Multiple Sclerosis

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT04240379
Collaborator
University Grenoble Alps (Other)
80
Enrollment
1
Location
21.9
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assessed the level of consciousness of MS patients suffering of cognitive and motor disorders. Understanding the awareness of the disease is crucial to allow better management of these patients. It has been shown, for other neurological pathologies, that a lack of awareness of deficits leads to inefficient rehabilitation and a disorder of understanding the impact of deficits in daily activities. Metacognition could be altered with age, so we will include participants between 18 and 60 years old.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Subject who have to do neurological assessement by the Multiple sclerosis Functional Composite (MSFC) will be enrolled.

    The patient will estimate the time to undergo the test. This time will be compared to the time really make by the patient to realise test.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Metacognition Assessment in Patient With Multiple Sclerosis
    Actual Study Start Date :
    Jun 11, 2020
    Actual Primary Completion Date :
    Apr 8, 2022
    Actual Study Completion Date :
    Apr 8, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Metacognitive precision [Day 1]

      Metacognitive precision based on Multiple Sclerosis Functional Composite (MSFC) score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of multiple sclerosis

    • Voluntary for participate to study

    Exclusion Criteria:

    • Neurological disease other than Multiple Sclerosis

    • psychiatric disease, other than depressiveness

    • illicit substance abuse

    • Persons referred to in Articles L1121-5 to 8 of the French Public Health Code

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Grenoble Alpes Grenoble France 38043

    Sponsors and Collaborators

    • University Hospital, Grenoble
    • University Grenoble Alps

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT04240379
    Other Study ID Numbers:
    • 38RC19.146
    • 2019-A01278-49
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Grenoble
    Multiple Sclerosis
    Multiple Sclerosis Functional Composite (MSFC)
    Metacognition
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Jun 1, 2022