Cognitive-motor Telerehabilitation in MS (CoMoTeMS)

May 4, 2026 updated by: Universitair Ziekenhuis Brussel

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Digit span backwards
Time Frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of working memory
0 weeks, 12 weeks, 24 weeks, 64 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in Corsi backwards
Time Frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of working memory
0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in Expanded Disability Status Scale (EDSS)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of disability in MS
0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in 6-Minute Walk Test (6MWT)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of walking performance
0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in 25-Foot Walk Test (25FWT)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of walking performance
0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in 9-Hole Peg Test (9HPT)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of upper extremity function
0 weeks, 12 weeks, 24 weeks, 64 weeks
MRI T1 3D BRAVO scan
Time Frame: 0 weeks, 12 weeks, 24 weeks
Cortical volume, volumes of white matter and deep grey matter
0 weeks, 12 weeks, 24 weeks
MRI T2 FLAIR 3D Cube scan
Time Frame: 0 weeks, 12 weeks, 24 weeks
Lesion volume
0 weeks, 12 weeks, 24 weeks
Synthetic MRI
Time Frame: 0 weeks, 12 weeks, 24 weeks
Contrast weighted images based on measurements of tissue properties from a single acquisition
0 weeks, 12 weeks, 24 weeks
resting-state EEG
Time Frame: 0 weeks, 12 weeks
functional connectivity using graph theoretical measures
0 weeks, 12 weeks
task-related EEG - auditory oddball paradigm
Time Frame: 0 weeks, 12 weeks
functional connectivity using graph theoretical measures, event-related potentials
0 weeks, 12 weeks
task-related EEG - adjusted SDMT paradigm
Time Frame: 0 weeks, 12 weeks
functional connectivity using graph theoretical measures, event-related potentials
0 weeks, 12 weeks
task-related EEG - n-back paradigm
Time Frame: 0 weeks, 12 weeks
functional connectivity using graph theoretical measures, event-related potentials
0 weeks, 12 weeks
Diffusion weighted image (DWI)
Time Frame: 0 weeks, 12 weeks, 24 weeks
structural connectivity using graph theoretical measures; diffusion tensor image parameters
0 weeks, 12 weeks, 24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Hospital Anxiety and Depression Scale (HADS)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of anxiety and depression
0 weeks, 12 weeks, 24 weeks, 64 weeks
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
0 weeks, 12 weeks, 24 weeks, 64 weeks
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
0 weeks, 12 weeks, 24 weeks, 64 weeks
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
0 weeks, 12 weeks, 24 weeks, 64 weeks
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
0 weeks, 12 weeks, 24 weeks, 64 weeks
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.
0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in Cognitive Leisure Activity Scale (CLAS)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of baseline cognitive activities
0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time Frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of baseline physical activities
0 weeks, 12 weeks, 24 weeks, 64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitair Ziekenhuis Brussel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National MS Center Melsbroek
Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guy Nagels, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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