Cognitive-motor Telerehabilitation in MS

Multiple Sclerosis Clinical Trial

— CoMoTeMS  

Official title:

Cognitive-motor Telerehabilitation in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355389
• Other study ID #: CoMoTeMS
• Secondary ID: 1SD5322N
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 2025

Study information

• Verified date: August 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Delphine Van Laethem
• Phone: +32 2 629 10 45
• Email: Delphine.Van.Laethem[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	National MS Center Melsbroek	Melsbroek

Sponsors (3)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	National MS Center Melsbroek, Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Hospital Anxiety and Depression Scale (HADS)	Measure of anxiety and depression	0 weeks, 12 weeks, 24 weeks, 64 weeks
Other	Change in Fatigue Scale for Motor and Cognitive functions (FSMC)	Measure of fatigue in MS	0 weeks, 12 weeks, 24 weeks, 64 weeks
Other	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
Other	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
Other	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
Other	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
Other	Change in Cognitive Leisure Activity Scale (CLAS)	Measure of baseline cognitive activities	0 weeks, 12 weeks, 24 weeks, 64 weeks
Other	Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ)	Measure of baseline physical activities	0 weeks, 12 weeks, 24 weeks, 64 weeks
Primary	Change in Digit span backwards	Measure of working memory	0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary	Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)	Measure of cognition in MS	0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary	Change in Corsi backwards	Measure of working memory	0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary	Change in Expanded Disability Status Scale (EDSS)	Measure of disability in MS	0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary	Change in 6-Minute Walk Test (6MWT)	Measure of walking performance	0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary	Change in 25-Foot Walk Test (25FWT)	Measure of walking performance	0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary	Change in 9-Hole Peg Test (9HPT)	Measure of upper extremity function	0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary	MRI T1 3D BRAVO scan	Cortical volume, volumes of white matter and deep grey matter	0 weeks, 12 weeks, 24 weeks
Secondary	MRI T2 FLAIR 3D Cube scan	Lesion volume	0 weeks, 12 weeks, 24 weeks
Secondary	Diffusion weighted image (DWI)	structural connectivity using graph theoretical measures; diffusion tensor image parameters	0 weeks, 12 weeks, 24 weeks
Secondary	Synthetic MRI	Contrast weighted images based on measurements of tissue properties from a single acquisition	0 weeks, 12 weeks, 24 weeks
Secondary	resting-state EEG	functional connectivity using graph theoretical measures	0 weeks, 12 weeks
Secondary	task-related EEG - auditory oddball paradigm	functional connectivity using graph theoretical measures, event-related potentials	0 weeks, 12 weeks
Secondary	task-related EEG - adjusted SDMT paradigm	functional connectivity using graph theoretical measures, event-related potentials	0 weeks, 12 weeks
Secondary	task-related EEG - n-back paradigm	functional connectivity using graph theoretical measures, event-related potentials	0 weeks, 12 weeks
Secondary	functional MRI - resting-state	cortical activity (BOLD)	0 weeks, 12 weeks, 24 weeks
Secondary	functional MRI - auditory oddball paradigm	event-related fMRI	0 weeks, 12 weeks, 24 weeks