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NCT04240379 Clinical Trial

Metacognition Assessment in Patient With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— METACOGSEP  

Official title:
Metacognition Assessment in Patient With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04240379
Other study ID # 38RC19.146
Secondary ID 2019-A01278-49
Status Completed
Phase
First received
Last updated
Start date June 11, 2020
Est. completion date April 8, 2022

Study information
Verified date May 2022
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 8, 2022
Est. primary completion date April 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Chu Grenoble Alpes Grenoble

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Grenoble University Grenoble Alps

Country where clinical trial is conducted

France, 

References & Publications (3)

Beatty WW, Monson N. Metamemory in multiple sclerosis. J Clin Exp Neuropsychol. 1991 Mar;13(2):309-27. — View Citation

Calabrese P. Neuropsychology of multiple sclerosis--an overview. J Neurol. 2006 Feb;253 Suppl 1:I10-5. Review. — View Citation

Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Metacognitive precision Metacognitive precision based on Multiple Sclerosis Functional Composite (MSFC) score Day 1
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