Cognitive-motor Telerehabilitation in MS

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Motor training; Behavioral: Cognitive training

• Registration Number: NCT05355389
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-05-02
• Study Start: 2022-09-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motor training group	Motor training	-
Cognitive training group	Cognitive training	-
Cognitive-motor training group	Motor training	-
Cognitive-motor training group	Cognitive training	-

Primary Outcome Measures

Name	Time	Method
Change in Digit span backwards	0 weeks, 12 weeks, 24 weeks, 64 weeks	Measure of working memory

Secondary Outcome Measures

Name	Time	Method
Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)	0 weeks, 12 weeks, 24 weeks, 64 weeks	Measure of cognition in MS
Change in Corsi backwards	0 weeks, 12 weeks, 24 weeks, 64 weeks	Measure of working memory
Change in Expanded Disability Status Scale (EDSS)	0 weeks, 12 weeks, 24 weeks, 64 weeks	Measure of disability in MS
Change in 6-Minute Walk Test (6MWT)	0 weeks, 12 weeks, 24 weeks, 64 weeks	Measure of walking performance
Change in 25-Foot Walk Test (25FWT)	0 weeks, 12 weeks, 24 weeks, 64 weeks	Measure of walking performance
MRI T1 3D BRAVO scan	0 weeks, 12 weeks, 24 weeks	Cortical volume, volumes of white matter and deep grey matter
Change in 9-Hole Peg Test (9HPT)	0 weeks, 12 weeks, 24 weeks, 64 weeks	Measure of upper extremity function
MRI T2 FLAIR 3D Cube scan	0 weeks, 12 weeks, 24 weeks	Lesion volume
Diffusion weighted image (DWI)	0 weeks, 12 weeks, 24 weeks	structural connectivity using graph theoretical measures; diffusion tensor image parameters
Synthetic MRI	0 weeks, 12 weeks, 24 weeks	Contrast weighted images based on measurements of tissue properties from a single acquisition
resting-state EEG	0 weeks, 12 weeks	functional connectivity using graph theoretical measures
task-related EEG - auditory oddball paradigm	0 weeks, 12 weeks	functional connectivity using graph theoretical measures, event-related potentials
task-related EEG - adjusted SDMT paradigm	0 weeks, 12 weeks	functional connectivity using graph theoretical measures, event-related potentials
task-related EEG - n-back paradigm	0 weeks, 12 weeks	functional connectivity using graph theoretical measures, event-related potentials

Trial Locations

Locations (2)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussel, Belgium

National MS Center Melsbroek; 🇧🇪 Melsbroek, Belgium