Cognitive-motor Telerehabilitation in MS (CoMoTeMS)

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Behavioral: Motor training; Behavioral: Cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT05355389

1SD5322N (Other Grant/Funding Number)

CoMoTeMS

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Cognitive-motor training group

Experimental group

Treatment:

Behavioral: Cognitive training

Behavioral: Motor training

Cognitive training group

Active Comparator group

Treatment:

Behavioral: Cognitive training

Motor training group

Active Comparator group

Treatment:

Behavioral: Motor training