About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cognitive training
- Motor training
Treatment groups
Sponsors and collaborators
Universitair Ziekenhuis Brussel
Lead sponsor
National MS Center Melsbroek
Collaborator
Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
Collaborator