Multiple Sclerosis Clinical Trial
— CoMoTeMSOfficial title:
Cognitive-motor Telerehabilitation in Multiple Sclerosis
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | May 2025 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Brussel | Brussel | |
Belgium | National MS Center Melsbroek | Melsbroek |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel | National MS Center Melsbroek, Research Foundation Flanders |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Hospital Anxiety and Depression Scale (HADS) | Measure of anxiety and depression | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Other | Change in Fatigue Scale for Motor and Cognitive functions (FSMC) | Measure of fatigue in MS | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Other | Change in Visual Analogue Scale (VAS) | VAS on the impact of perceived cognitive symptoms on daily life | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Other | Change in 36-Item Short Form Survey (SF-36) | Measure of quality of life Only Dutch-speaking participants | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Other | Change in Multiple Sclerosis Impact Scale-29 (MSIS-29) | Measure of quality of life in MS Only Dutch-speaking participants | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Other | Change in Multiple Sclerosis-59 (SEP-59) | Measure of quality of life, combination of SF-36 and MS-specific questions Only French-speaking participants Of note, the French title of this questionnaire is Sclérose En Plaques-59. | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Other | Change in Cognitive Leisure Activity Scale (CLAS) | Measure of baseline cognitive activities | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Other | Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) | Measure of baseline physical activities | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Primary | Change in Digit span backwards | Measure of working memory | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Secondary | Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) | Measure of cognition in MS | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Secondary | Change in Corsi backwards | Measure of working memory | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Secondary | Change in Expanded Disability Status Scale (EDSS) | Measure of disability in MS | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Secondary | Change in 6-Minute Walk Test (6MWT) | Measure of walking performance | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Secondary | Change in 25-Foot Walk Test (25FWT) | Measure of walking performance | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Secondary | Change in 9-Hole Peg Test (9HPT) | Measure of upper extremity function | 0 weeks, 12 weeks, 24 weeks, 64 weeks | |
Secondary | MRI T1 3D BRAVO scan | Cortical volume, volumes of white matter and deep grey matter | 0 weeks, 12 weeks, 24 weeks | |
Secondary | MRI T2 FLAIR 3D Cube scan | Lesion volume | 0 weeks, 12 weeks, 24 weeks | |
Secondary | Diffusion weighted image (DWI) | structural connectivity using graph theoretical measures; diffusion tensor image parameters | 0 weeks, 12 weeks, 24 weeks | |
Secondary | Synthetic MRI | Contrast weighted images based on measurements of tissue properties from a single acquisition | 0 weeks, 12 weeks, 24 weeks | |
Secondary | resting-state EEG | functional connectivity using graph theoretical measures | 0 weeks, 12 weeks | |
Secondary | task-related EEG - auditory oddball paradigm | functional connectivity using graph theoretical measures, event-related potentials | 0 weeks, 12 weeks | |
Secondary | task-related EEG - adjusted SDMT paradigm | functional connectivity using graph theoretical measures, event-related potentials | 0 weeks, 12 weeks | |
Secondary | task-related EEG - n-back paradigm | functional connectivity using graph theoretical measures, event-related potentials | 0 weeks, 12 weeks | |
Secondary | functional MRI - resting-state | cortical activity (BOLD) | 0 weeks, 12 weeks, 24 weeks | |
Secondary | functional MRI - auditory oddball paradigm | event-related fMRI | 0 weeks, 12 weeks, 24 weeks |
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