Last updated: February 6, 2024
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting
Phase
N/A
Condition
Multiple Sclerosis
Memory Loss
Memory Problems
Treatment
Ecological evaluation
Classical cognitive evaluation of several domains:
Telerehabilitation : active procedure
Clinical Study ID
NCT05611047
CHUBX 2021/60
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female;
- Age 18-55 years;
- Native French speaking;
- Definite diagnosis of Relapsing-remitting MS (RRMS) according to McDonald 2017criteria;
- Disease duration> 12 months and ≤ 15 years;
- Computerized-Screening Cognitive Test (CSCT) score ≤ - 1.282 Standard Deviations (SD) (10th percentile) and/or cognitive complaint;
- 3 scores -1 SDa or 2 scores -1.5 SDb at least 2 of 5 baseline preselectionneuropsychological battery tests in one of the following domains: processing speed orattention or working memory (SDMT, subtests alert, divided attention, visual scanningfor selective attention, TAP and subtest working memory of the WAIS IV) and SDMT scorenot ≤ -3 SD;
- Able to use a computer with Windows operating system, an internet connection;
- Being affiliated to health insurance
- Having signed an informed consent (at the latest on the day of inclusion and beforeany examination required by research)
Exclusion
Exclusion Criteria:
- Previous history of other neurological disease;
- Psychiatric comorbidity including severe depression according to Diagnostic andStatistical Manual-IV (DSM-IV);
- Current dependence on alcohol or other addiction to toxic;
- Disabling visual or motor problems preventing participation to neuropsychologicalassessments;
- Change of psychotropic drug or disease-modifying therapies since less than one month;
- MS relapse in the month preceding the inclusion visit
- Illiteracy, ie: unable to count or to read;
- Acquisition disorders: dyslexia, dysphasia, dyscalculia and dyspraxia;
- Pregnant or breastfeeding women;
- Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their libertyby a judicial or administrative decision, minors, persons of legal age who are theobject of a legal protection measure or unable to express their consent).
Study Design
Total Participants: 150
Treatment Group(s): 6
Primary Treatment: Ecological evaluation
Phase:
Study Start date:
February 21, 2023
Estimated Completion Date:
February 28, 2025
Connect with a study center
CHU de Bordeaux - Service de neurologie
Bordeaux,
FranceActive - Recruiting
CHU de Clermont-Ferrand - Service de neurologie
Clermont-Ferrand,
FranceSite Not Available
CHU de Dijon-Bourgogne - Service de neurologie
Dijon,
FranceSite Not Available
CH de Dunkerque - Service de neurologie
Dunkerque,
FranceSite Not Available
Hôpital Saint Vincent de Paul - Service de neurologie
Lille,
FranceSite Not Available
CHU de Montpellier - Service de neurologie
Montpellier,
FranceSite Not Available
CHI Hôpital de Poissy Saint Germain en Laye - Service de neurologie
Poissy,
FranceSite Not Available
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