Metacognition Assessment in Patient With Multiple Sclerosis (METACOGSEP)

May 31, 2022 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will be proposed to subject :

  • Male or female with diagnosis of MS,
  • admitted in neurological unit for passing the MSFC (Multiple Sclerosis Functionnal Composite) test
  • who respect selection criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metacognitive precision
Time Frame: Day 1
Metacognitive precision based on Multiple Sclerosis Functional Composite (MSFC) score
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

University Grenoble Alps

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Actual)

April 8, 2022

Study Completion (Actual)

April 8, 2022

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC19.146
  • 2019-A01278-49 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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