CoMoTeMS: Cognitive-motor Telerehabilitation in MS

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05355389

Collaborator

National MS Center Melsbroek (Other), Research Foundation Flanders (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Behavioral: Cognitive training Behavioral: Motor training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Cognitive-motor Telerehabilitation in Multiple Sclerosis

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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.

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

Other Names:

BrainStim

Active Comparator: Motor training group

Behavioral: Motor training

Outcome Measures

Primary Outcome Measures

Change in Digit span backwards [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of working memory

Secondary Outcome Measures

Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of cognition in MS
Change in Corsi backwards [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of working memory
Change in 6-Minute Walk Test (6MWT) [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of walking performance
MRI T1 3D BRAVO scan [0 weeks, 12 weeks, 24 weeks]
Cortical volume, volumes of white matter and deep grey matter
MRI T2 FLAIR 3D Cube scan [0 weeks, 12 weeks, 24 weeks]
Lesion volume
Diffusion weighted image (DWI) [0 weeks, 12 weeks, 24 weeks]
structural connectivity using graph theoretical measures
Synthetic MRI [0 weeks, 12 weeks, 24 weeks]
Contrast weighted images based on measurements of tissue properties from a single acquisition
resting-state EEG [0 weeks, 12 weeks]
functional connectivity using graph theoretical measures
task-related EEG - auditory oddball paradigm [0 weeks, 12 weeks]
functional connectivity using graph theoretical measures, event-related potentials
task-related EEG - adjusted SDMT paradigm [0 weeks, 12 weeks]
functional connectivity using graph theoretical measures, event-related potentials
task-related EEG - n-back paradigm [0 weeks, 12 weeks]
functional connectivity using graph theoretical measures, event-related potentials

Other Outcome Measures

Change in Hospital Anxiety and Depression Scale (HADS) [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of anxiety and depression
Change in Fatigue Scale for Motor and Cognitive functions (FSMC) [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of fatigue in MS
Change in Visual Analogue Scale (VAS) [0 weeks, 12 weeks, 24 weeks, 64 weeks]
VAS on the impact of perceived cognitive symptoms on daily life
Change in 36-Item Short Form Survey (SF-36) [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of quality of life Only Dutch-speaking participants
Change in Multiple Sclerosis Impact Scale-29 (MSIS-29) [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of quality of life in MS Only Dutch-speaking participants
Change in Multiple Sclerosis-59 (SEP-59) [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.
Change in Cognitive Leisure Activity Scale (CLAS) [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of baseline cognitive activities
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) [0 weeks, 12 weeks, 24 weeks, 64 weeks]
Measure of baseline physical activities

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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