Cognitive-motor Telerehabilitation in MS (CoMoTeMS)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Cognitive training; Behavioral: Motor training

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Delphine Van Laethem; Phone Number: +32 2 629 10 45; Email: Delphine.Van.Laethem@vub.be
• Study Contact Backup: Name: Guy Nagels; Phone Number: +32 2 477 64 10; Email: guy.nagels@vub.be

Study Locations

• Belgium
  • Brussels, Belgium
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Guy Nagels
  • Melsbroek, Belgium
    • Recruiting
    • National MS Center Melsbroek
    • Contact: Miguel D'Haeseleer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-motor training group	Behavioral: Cognitive training; For the cognitive treatment intervention the widely used cognitive training program RehaCom will be used. This is a computer-aided program with more than 30 modules focusing on different domains of cognition. RehaCom has shown improvements in verbal learning, visuospatial memory, information processing speed, attention, executive functions, depression, fatigue and quality of life in PwMS (PMID 31927200, 28116167, 19825502, 23192417). Patients will train on their home computer without direct therapist supervision, using three RehaCom modules that are focused on improving working memory. Both patients in the combined intervention and the cognitive intervention group will be doing a 45-minute computer session respectively one and two days per week for a total of 12 weeks.; Other Names: BrainStim; Behavioral: Motor training; For the motor treatment intervention a patient-tailored aerobic training program will be used. Based on their baseline physical activity level patients can choose out of a number of aerobic activities of either mild, moderate or strenuous intensity, with a total training time of 90 minutes for the motor intervention group and 45 minutes for the combined intervention group, divided over at least two training sessions per week of at least 15 minutes per session. The training will be carried out individually at home, without therapist supervision. All physical activities will be logged using the sport watch equipped with a heart rate sensor and an accelerometer. Training intensity will be assessed using the patient's heart rate and the Rating of Perceived Exertion scale.
Active Comparator: Cognitive training group	Behavioral: Cognitive training; For the cognitive treatment intervention the widely used cognitive training program RehaCom will be used. This is a computer-aided program with more than 30 modules focusing on different domains of cognition. RehaCom has shown improvements in verbal learning, visuospatial memory, information processing speed, attention, executive functions, depression, fatigue and quality of life in PwMS (PMID 31927200, 28116167, 19825502, 23192417). Patients will train on their home computer without direct therapist supervision, using three RehaCom modules that are focused on improving working memory. Both patients in the combined intervention and the cognitive intervention group will be doing a 45-minute computer session respectively one and two days per week for a total of 12 weeks.; Other Names: BrainStim
Active Comparator: Motor training group	Behavioral: Motor training; For the motor treatment intervention a patient-tailored aerobic training program will be used. Based on their baseline physical activity level patients can choose out of a number of aerobic activities of either mild, moderate or strenuous intensity, with a total training time of 90 minutes for the motor intervention group and 45 minutes for the combined intervention group, divided over at least two training sessions per week of at least 15 minutes per session. The training will be carried out individually at home, without therapist supervision. All physical activities will be logged using the sport watch equipped with a heart rate sensor and an accelerometer. Training intensity will be assessed using the patient's heart rate and the Rating of Perceived Exertion scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Digit span backwards	Measure of working memory	0 weeks, 12 weeks, 24 weeks, 64 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hospital Anxiety and Depression Scale (HADS)	Measure of anxiety and depression	0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in Fatigue Scale for Motor and Cognitive functions (FSMC)	Measure of fatigue in MS	0 weeks, 12 weeks, 24 weeks, 64 weeks
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
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
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
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
Change in Cognitive Leisure Activity Scale (CLAS)	Measure of baseline cognitive activities	0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ)	Measure of baseline physical activities	0 weeks, 12 weeks, 24 weeks, 64 weeks

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: National MS Center Melsbroek; Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
• Investigators: Principal Investigator: Guy Nagels, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel

Publications and helpful links

General Publications

• Van Laethem D, Van de Steen F, Kos D, Naeyaert M, Van Schuerbeek P, D'Haeseleer M, D'Hooghe MB, Van Schependom J, Nagels G. Cognitive-motor telerehabilitation in multiple sclerosis (CoMoTeMS): study protocol for a randomised controlled trial. Trials. 2022 Sep 14;23(1):778. doi: 10.1186/s13063-022-06697-9.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: multiple sclerosis; cognitive rehabilitation; telerehabilitation; cognitive-motor rehabilitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Neurological Rehabilitation; Cognitive Training
• Other Study ID Numbers: CoMoTeMS; 1SD5322N (Other Grant/Funding Number: Fonds Wetenschappelijk Onderzoek (FWO))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No