NCT05355389 Cognitive-motor Telerehabilitation in MS
| NCT ID | NCT05355389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2022-09-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary goal of this project is providing evidence that a home-based combined cognitive-motor training program improves cognition in persons with multiple sclerosis (MS), compared to single cognitive and motor rehabilitation. Secondary goals are to assess the effects on walking performance and to identify the mechanisms of improvement and predictors of treatment response. The main backbone of this project will be a randomized controlled two-centre clinical trial, in which an at-home computerised cognitive-motor rehabilitation program using telemedicine aimed at improving working memory in persons with MS will be evaluated. Based on the information gathered during this trial, possible mechanisms of improvement will be identified by analysing anatomical and neurophysiological changes on structural MRI and resting-state and task-related EEG before and after rehabilitation. Furthermore, factors that can predict treatment response to the rehabilitation program will be identified.
Eligibility 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
Contact & Investigator
Guy Nagels
PRINCIPAL INVESTIGATOR
Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel
Frequently Asked Questions
Who can join the NCT05355389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05355389 currently recruiting?
Yes, NCT05355389 is actively recruiting participants. Contact the research team at Delphine.Van.Laethem@vub.be for enrollment information.
Where is the NCT05355389 trial being conducted?
This trial is being conducted at Brussels, Belgium, Melsbroek, Belgium.
Who is sponsoring the NCT05355389 clinical trial?
NCT05355389 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Guy Nagels at Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel. The trial plans to enroll 90 participants.
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