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| ID | Type | Description | Link |
|---|---|---|---|
| 1SD5322N | Other Grant/Funding Number | Fonds Wetenschappelijk Onderzoek (FWO) |
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| Name | Class |
|---|---|
| National MS Center Melsbroek | OTHER |
| Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek) | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-motor training group | Experimental |
| |
| Cognitive training group | Active Comparator |
| |
| Motor training group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Digit span backwards | Measure of working memory | 0 weeks, 12 weeks, 24 weeks, 64 weeks |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delphine Van Laethem | Contact | +32 2 629 10 45 | Delphine.Van.Laethem@vub.be | |
| Guy Nagels | Contact | +32 2 477 64 10 | guy.nagels@vub.be |
| Name | Affiliation | Role |
|---|---|---|
| Guy Nagels | Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36104820 | Derived | 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Patients will be randomly assigned to either the cognitive-motor, the cognitive or the motor telerehabilitation group, stratified by baseline activity level and cognition.
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The study will be double-blinded: patients will not be made aware of the rationale and predictions of the study. The teleconsultations will be carried out by a trained MS nurse, while the baseline and follow-up testing and analyses are carried out by an investigator who is blinded to the treatment allocation of the patients.
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| 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. |
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| 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 |
| Diffusion weighted image (DWI) | structural connectivity using graph theoretical measures; diffusion tensor image parameters | 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 |
| 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 |
| National MS Center Melsbroek | Recruiting | Melsbroek | Belgium |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |