Home-based cognitive-motor training for multiple sclerosis
Cognitive-motor Telerehabilitation in Multiple Sclerosis
NA · Universitair Ziekenhuis Brussel · NCT05355389
This study is testing whether a home-based program that combines thinking and movement exercises can help people with multiple sclerosis more than traditional separate treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel (other) |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT05355389 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of a home-based cognitive-motor training program for individuals with multiple sclerosis (MS). It will compare the combined cognitive-motor rehabilitation approach to traditional single cognitive and motor rehabilitation methods. The study will utilize a randomized controlled design across two centers, incorporating telemedicine to enhance accessibility. Participants will undergo assessments using MRI and EEG to identify changes in brain function and structure, as well as predictors of treatment response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with clinically definite multiple sclerosis and specific cognitive impairments.
Not a fit: Patients with recent cognitive rehabilitation or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance cognitive function and walking performance in patients with multiple sclerosis.
How similar studies have performed: Previous studies have shown promise in cognitive-motor rehabilitation for MS, but this specific approach using telerehabilitation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically definite multiple sclerosis (revised McDonald criteria 2017) * Expanded Disability Status Scale (EDSS) below 6.0 * Digit span backwards z-score between \[-3 and -0.5\] standard deviations below the median of the normative values * Age between 18 and 65 * Able to safely perform motor rehabilitation in the home situation (assessed by rehabilitation physician and/or occupational or physiotherapist) Exclusion Criteria: * Cognitive rehabilitation within six months before inclusion * Inpatient multidisciplinary rehabilitation program within three months before inclusion or planned inpatient program during trial * Start of or switch in immunomodulator treatment within three months before inclusion * Less than one month post-exacerbation * Major psychiatric or medical disorder that could influence cognitive functions * Combined vision with optimal correction below 0.6 on Snellen Visual Acuity Test * Unable or unwilling to undergo EEG or MRI * Refusing informed consent
Where this trial is running
Brussels and 1 other locations
- Universitair Ziekenhuis Brussel — Brussels, Belgium (RECRUITING)
- National MS Center Melsbroek — Melsbroek, Belgium (RECRUITING)
Study contacts
- Principal investigator: Guy Nagels — Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel
- Study coordinator: Delphine Van Laethem
- Email: Delphine.Van.Laethem@vub.be
- Phone: +32 2 629 10 45
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.
Conditions: Multiple Sclerosis, multiple sclerosis, cognitive rehabilitation, cognitive-motor rehabilitation, telerehabilitation