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NCT Number: NCT05355389

Cognitive-motor Telerehabilitation in MS

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive training

Behavioral

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

motor training

Behavioral

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.

Primary outcomes

  1. Change in Digit span backwards

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of working memory

Secondary outcomes

  1. Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of cognition in MS

  2. Change in Corsi backwards

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of working memory

  3. Change in Expanded Disability Status Scale (EDSS)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of disability in MS

  4. Change in 6-Minute Walk Test (6MWT)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of walking performance

  5. Change in 25-Foot Walk Test (25FWT)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of walking performance

  6. Change in 9-Hole Peg Test (9HPT)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of upper extremity function

  7. MRI T1 3D BRAVO scan

    Time frame: 0 weeks, 12 weeks, 24 weeks

    Cortical volume, volumes of white matter and deep grey matter

  8. MRI T2 FLAIR 3D Cube scan

    Time frame: 0 weeks, 12 weeks, 24 weeks

    Lesion volume

  9. Diffusion weighted image (DWI)

    Time frame: 0 weeks, 12 weeks, 24 weeks

    structural connectivity using graph theoretical measures; diffusion tensor image parameters

  10. Synthetic MRI

    Time frame: 0 weeks, 12 weeks, 24 weeks

    Contrast weighted images based on measurements of tissue properties from a single acquisition

  11. resting-state EEG

    Time frame: 0 weeks, 12 weeks

    functional connectivity using graph theoretical measures

  12. task-related EEG - auditory oddball paradigm

    Time frame: 0 weeks, 12 weeks

    functional connectivity using graph theoretical measures, event-related potentials

  13. task-related EEG - adjusted SDMT paradigm

    Time frame: 0 weeks, 12 weeks

    functional connectivity using graph theoretical measures, event-related potentials

  14. task-related EEG - n-back paradigm

    Time frame: 0 weeks, 12 weeks

    functional connectivity using graph theoretical measures, event-related potentials

Other outcomes

  1. Change in Hospital Anxiety and Depression Scale (HADS)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of anxiety and depression

  2. Change in Fatigue Scale for Motor and Cognitive functions (FSMC)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of fatigue in MS

  3. Change in Visual Analogue Scale (VAS)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    VAS on the impact of perceived cognitive symptoms on daily life

  4. Change in 36-Item Short Form Survey (SF-36)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of quality of life Only Dutch-speaking participants

  5. Change in Multiple Sclerosis Impact Scale-29 (MSIS-29)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of quality of life in MS Only Dutch-speaking participants

  6. Change in Multiple Sclerosis-59 (SEP-59)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    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.

  7. Change in Cognitive Leisure Activity Scale (CLAS)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of baseline cognitive activities

  8. Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks

    Measure of baseline physical activities

Study contacts

Contact information is provided by the study sponsor or research team.

Delphine Van Laethem

CONTACT

[email protected]

+32 2 629 10 45

Guy Nagels

CONTACT

[email protected]

+32 2 477 64 10

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • National MS Center Melsbroek
  • Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)

Registry information

Official study title

Cognitive-motor Telerehabilitation in Multiple Sclerosis

Acronym: CoMoTeMS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 2, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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