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Metacognition Assessment in Patient With Multiple Sclerosis (METACOGSEP)

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: NCT04240379
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
University Grenoble Alps
Information provided by (Responsible Party):
University Hospital, Grenoble

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
Multiple Sclerosis

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Metacognition Assessment in Patient With Multiple Sclerosis
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Metacognitive precision [ Time Frame: Day 1 ]
    Metacognitive precision based on Multiple Sclerosis Functional Composite (MSFC) score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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): NCT04240379


Contacts
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Contact: Audrey MAZANCIEUX, PhD 33 6 41 99 61 52 audrey.mazancieux@gmail.com
Contact: Olivier CASEZ, MD 33 4 76 76 58 71 OCasez@chu-grenbole.fr

Locations
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France
Chu Grenoble Alpes Recruiting
Grenoble, France, 38043
Contact: Audrey MAZANCIEUX         
Principal Investigator: Olivier CASSEZ         
Sponsors and Collaborators
University Hospital, Grenoble
University Grenoble Alps
Publications of Results:
Other Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04240379    
Other Study ID Numbers: 38RC19.146
2019-A01278-49 ( Other Identifier: ID RCB )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases