Multiple SclerosisCoMoTeMSNCT05355389
Cognitive-motor Telerehabilitation in MS
A study testing Cognitive training and Motor training in people with Multiple Sclerosis, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cognitive training and Motor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels
Guy Nagels
- Recruiting
National MS Center Melsbroek
Melsbroek
Miguel D'Haeseleer
About this study
Official 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Cognitive training, Motor training
- Keywords
- multiple sclerosis, cognitive rehabilitation, cognitive-motor rehabilitation, telerehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Also called BrainStim
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.
Motor trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-motor training group | Experimental | Not described Receives: Behavioral: Cognitive training; Behavioral: Motor training |
| Cognitive training group | Active comparator | Not described Receives: Behavioral: Cognitive training |
| Motor training group | Active comparator | Not described Receives: Behavioral: Motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Digit span backwards
Measure of working memory
Measured: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary outcomes (14)
Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Measure of cognition in MS
Measured: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in Corsi backwards
Measure of working memory
Measured: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in Expanded Disability Status Scale (EDSS)
Measure of disability in MS
Measured: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in 6-Minute Walk Test (6MWT)
Measure of walking performance
Measured: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in 25-Foot Walk Test (25FWT)
Measure of walking performance
Measured: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in 9-Hole Peg Test (9HPT)
Measure of upper extremity function
Measured: 0 weeks, 12 weeks, 24 weeks, 64 weeks
MRI T1 3D BRAVO scan
Cortical volume, volumes of white matter and deep grey matter
Measured: 0 weeks, 12 weeks, 24 weeks
MRI T2 FLAIR 3D Cube scan
Lesion volume
Measured: 0 weeks, 12 weeks, 24 weeks
Diffusion weighted image (DWI)
structural connectivity using graph theoretical measures; diffusion tensor image parameters
Measured: 0 weeks, 12 weeks, 24 weeks
Synthetic MRI
Contrast weighted images based on measurements of tissue properties from a single acquisition
Measured: 0 weeks, 12 weeks, 24 weeks
resting-state EEG
functional connectivity using graph theoretical measures
Measured: 0 weeks, 12 weeks
task-related EEG - auditory oddball paradigm
functional connectivity using graph theoretical measures, event-related potentials
Measured: 0 weeks, 12 weeks
task-related EEG - adjusted SDMT paradigm
functional connectivity using graph theoretical measures, event-related potentials
Measured: 0 weeks, 12 weeks
task-related EEG - n-back paradigm
functional connectivity using graph theoretical measures, event-related potentials
Measured: 0 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to either the cognitive-motor, the cognitive or the motor telerehabilitation group, stratified by baseline activity level and cognition.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- National MS Center Melsbroek, Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
- Responsible party
- Sponsor
- Investigators
- Guy Nagels, Principal investigator, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355389
- Sponsor's protocol ID
- CoMoTeMS
- Other IDs
- 1SD5322N
- Acronym
- CoMoTeMS
- Status last verified
- May 2026
- First submitted
- 14 Apr 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36104820
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-motor Telerehabilitation in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05355389
- Acronym / sponsor ID
- CoMoTeMS / CoMoTeMS
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, cognitive rehabilitation, cognitive-motor rehabilitation, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- National MS Center Melsbroek, Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomly assigned to either the cognitive-motor, the cognitive or the motor telerehabilitation group, stratified by baseline activity level and cognition.
| Arm | Type | Receives |
|---|---|---|
| Cognitive-motor training group | Experimental | Behavioral: Cognitive training, Behavioral: Motor training |
| Cognitive training group | Active comparator | Behavioral: Cognitive training |
| Motor training group | Active comparator | Behavioral: Motor training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingAlso: BrainStimFor 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. | Behavioural | Cognitive training group, Cognitive-motor training group |
| Motor trainingFor 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. | Behavioural | Cognitive-motor training group, Motor training group |
Primary outcome
Change in Digit span backwards
Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of working memory
14 secondary outcomes
Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Change in Corsi backwards
Time frame: 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
Change in 6-Minute Walk Test (6MWT)
Time frame: 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
Change in 9-Hole Peg Test (9HPT)
Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
MRI T1 3D BRAVO scan
Time frame: 0 weeks, 12 weeks, 24 weeks
MRI T2 FLAIR 3D Cube scan
Time frame: 0 weeks, 12 weeks, 24 weeks
Diffusion weighted image (DWI)
Time frame: 0 weeks, 12 weeks, 24 weeks
Synthetic MRI
Time frame: 0 weeks, 12 weeks, 24 weeks
resting-state EEG
Time frame: 0 weeks, 12 weeks
task-related EEG - auditory oddball paradigm
Time frame: 0 weeks, 12 weeks
task-related EEG - adjusted SDMT paradigm
Time frame: 0 weeks, 12 weeks
task-related EEG - n-back paradigm
Time frame: 0 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 36104820Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guy Nagels principal investigator
Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training and Motor training in people with Multiple Sclerosis, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine Van Laethem (+32 2 629 10 45, Delphine.Van.Laethem@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Digit span backwards (time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05355389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.