Telerehabilitation for cognitive impairment in multiple sclerosis
Multicentre Randomized Blinded Controlled Study of Specific Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis Using Mixed Evaluation and Ecological Validity
This study is testing whether a remote rehabilitation program can help people with multiple sclerosis improve their thinking skills, like memory and attention.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 7 sites (Bordeaux and 6 other locations) |
| Trial ID | NCT05611047 on ClinicalTrials.gov |
What this trial studies
This study focuses on addressing cognitive impairment (CI) in individuals with multiple sclerosis (MS), a condition that significantly affects the quality of life and daily functioning. It employs a telerehabilitation approach, utilizing clinical assessments and cognitive evaluations to tailor interventions for participants. The study aims to improve cognitive functions such as information processing speed, attention, and memory through active procedures delivered remotely. Participants will be monitored and assessed using standardized cognitive tests to evaluate the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are French-speaking adults aged 18-55 with a confirmed diagnosis of relapsing-remitting multiple sclerosis and specific cognitive impairments.
Not a fit: Patients with severe cognitive impairment or those unable to use a computer and internet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cognitive functioning and overall quality of life for patients with multiple sclerosis.
How similar studies have performed: Other studies have shown promising results with telerehabilitation approaches for cognitive impairment, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female; * Age 18-55 years; * Native French speaking; * Definite diagnosis of Relapsing-remitting MS (RRMS) according to McDonald 2017 criteria; * 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 preselection neuropsychological battery tests in one of the following domains: processing speed or attention or working memory (SDMT, subtests alert, divided attention, visual scanning for selective attention, TAP and subtest working memory of the WAIS IV) and SDMT score not ≤ -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 before any examination required by research) Exclusion Criteria: * Previous history of other neurological disease; * Psychiatric comorbidity including severe depression according to Diagnostic and Statistical Manual-IV (DSM-IV); * Current dependence on alcohol or other addiction to toxic; * Disabling visual or motor problems preventing participation to neuropsychological assessments; * 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 liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
Where this trial is running
Bordeaux and 6 other locations
- CHU de Bordeaux - Service de neurologie — Bordeaux, France (Recruiting)
- CHU de Clermont-Ferrand - Service de neurologie — Clermont-Ferrand, France (Not_yet_recruiting)
- CHU de Dijon-Bourgogne - Service de neurologie — Dijon, France (Not_yet_recruiting)
- CH de Dunkerque - Service de neurologie — Dunkerque, France (Not_yet_recruiting)
- Hôpital Saint Vincent de Paul - Service de neurologie — Lille, France (Not_yet_recruiting)
- CHU de Montpellier - Service de neurologie — Montpellier, France (Not_yet_recruiting)
- CHI Hôpital de Poissy Saint Germain en Laye - Service de neurologie — Poissy, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Aurélie RUET, Prof — University Hospital, Bordeaux
- Study coordinator: Aurélie RUET, Prof
- Email: aurelie.ruet@chu-bordeaux.fr
- Phone: 05 56 79 55 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.