Clinical trial NCT05355389: Cognitive-motor Telerehabilitation in MS
Official title: Cognitive-motor Telerehabilitation in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
cognitive rehabilitation
cognitive-motor rehabilitation
telerehabilitation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: National MS Center Melsbroek
name: Research Foundation - Flanders (FWO: Fonds Wetenschappelijk Onderzoek)
First posted: 2022-05-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Digit span backwards
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary outcomes:
measure: Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in Corsi backwards
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in Expanded Disability Status Scale (EDSS)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in 6-Minute Walk Test (6MWT)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in 25-Foot Walk Test (25FWT)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in 9-Hole Peg Test (9HPT)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: MRI T1 3D BRAVO scan
timeFrame: 0 weeks, 12 weeks, 24 weeks
measure: MRI T2 FLAIR 3D Cube scan
timeFrame: 0 weeks, 12 weeks, 24 weeks
measure: Diffusion weighted image (DWI)
timeFrame: 0 weeks, 12 weeks, 24 weeks
measure: Synthetic MRI
timeFrame: 0 weeks, 12 weeks, 24 weeks
measure: resting-state EEG
timeFrame: 0 weeks, 12 weeks
measure: task-related EEG - auditory oddball paradigm
timeFrame: 0 weeks, 12 weeks
measure: task-related EEG - adjusted SDMT paradigm
timeFrame: 0 weeks, 12 weeks
measure: task-related EEG - n-back paradigm
timeFrame: 0 weeks, 12 weeks
Other outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in Fatigue Scale for Motor and Cognitive functions (FSMC)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in Visual Analogue Scale (VAS)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in 36-Item Short Form Survey (SF-36)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in Multiple Sclerosis-59 (SEP-59)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in Cognitive Leisure Activity Scale (CLAS)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
measure: Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Melsbroek
country: Belgium
facility: National MS Center Melsbroek
Study officials:
affiliation: Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel
name: Guy Nagels
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.