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Recruiting NCT05355389

Cognitive-motor Telerehabilitation in MS

No phase Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive training, Motor training.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cognitive-motor Telerehabilitation in Multiple Sclerosis

Overview

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.

Interventions

  • 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 ther
  • 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 in

Primary outcome measures

  • Change in Digit span backwards [Time frame: 0 weeks, 12 weeks, 24 weeks, 64 weeks]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Belgium · 2 centers
  • Universitair Ziekenhuis Brussel — Brussels
  • National MS Center Melsbroek — Melsbroek

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. PMID 36104820

Identifiers

NCT: NCT05355389 · CoMoTeMS · 1SD5322N

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗