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Cognitive-motor Telerehabilitation in MS (CoMoTeMS)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cognitive training
Motor training
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, cognitive rehabilitation, cognitive-motor rehabilitation, telerehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universitair Ziekenhuis BrusselRecruiting
  • National MS Center MelsbroekRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Cognitive-motor training group

Cognitive training group

Motor training group

Arm Description

Outcomes

Primary Outcome Measures

Change in Digit span backwards
Measure of working memory

Secondary Outcome Measures

Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Measure of cognition in MS
Change in Corsi backwards
Measure of working memory
Change in Expanded Disability Status Scale (EDSS)
Measure of disability in MS
Change in 6-Minute Walk Test (6MWT)
Measure of walking performance
Change in 25-Foot Walk Test (25FWT)
Measure of walking performance
Change in 9-Hole Peg Test (9HPT)
Measure of upper extremity function
MRI T1 3D BRAVO scan
Cortical volume, volumes of white matter and deep grey matter
MRI T2 FLAIR 3D Cube scan
Lesion volume
Diffusion weighted image (DWI)
structural connectivity using graph theoretical measures; diffusion tensor image parameters
Synthetic MRI
Contrast weighted images based on measurements of tissue properties from a single acquisition
resting-state EEG
functional connectivity using graph theoretical measures
task-related EEG - auditory oddball paradigm
functional connectivity using graph theoretical measures, event-related potentials
task-related EEG - adjusted SDMT paradigm
functional connectivity using graph theoretical measures, event-related potentials
task-related EEG - n-back paradigm
functional connectivity using graph theoretical measures, event-related potentials
functional MRI - resting-state
cortical activity (BOLD)
functional MRI - auditory oddball paradigm
event-related fMRI

Full Information

First Posted
April 14, 2022
Last Updated
August 29, 2023
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
National MS Center Melsbroek, Research Foundation Flanders
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1. Study Identification

Unique Protocol Identification Number
NCT05355389
Brief Title
Cognitive-motor Telerehabilitation in MS
Acronym
CoMoTeMS
Official Title
Cognitive-motor Telerehabilitation in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
National MS Center Melsbroek, Research Foundation Flanders

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, cognitive rehabilitation, cognitive-motor rehabilitation, telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-motor training group
Arm Type
Experimental
Arm Title
Cognitive training group
Arm Type
Active Comparator
Arm Title
Motor training group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Other Intervention Name(s)
BrainStim
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motor training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Digit span backwards
Description
Measure of working memory
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Secondary Outcome Measure Information:
Title
Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Description
Measure of cognition in MS
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in Corsi backwards
Description
Measure of working memory
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in Expanded Disability Status Scale (EDSS)
Description
Measure of disability in MS
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in 6-Minute Walk Test (6MWT)
Description
Measure of walking performance
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in 25-Foot Walk Test (25FWT)
Description
Measure of walking performance
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in 9-Hole Peg Test (9HPT)
Description
Measure of upper extremity function
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
MRI T1 3D BRAVO scan
Description
Cortical volume, volumes of white matter and deep grey matter
Time Frame
0 weeks, 12 weeks, 24 weeks
Title
MRI T2 FLAIR 3D Cube scan
Description
Lesion volume
Time Frame
0 weeks, 12 weeks, 24 weeks
Title
Diffusion weighted image (DWI)
Description
structural connectivity using graph theoretical measures; diffusion tensor image parameters
Time Frame
0 weeks, 12 weeks, 24 weeks
Title
Synthetic MRI
Description
Contrast weighted images based on measurements of tissue properties from a single acquisition
Time Frame
0 weeks, 12 weeks, 24 weeks
Title
resting-state EEG
Description
functional connectivity using graph theoretical measures
Time Frame
0 weeks, 12 weeks
Title
task-related EEG - auditory oddball paradigm
Description
functional connectivity using graph theoretical measures, event-related potentials
Time Frame
0 weeks, 12 weeks
Title
task-related EEG - adjusted SDMT paradigm
Description
functional connectivity using graph theoretical measures, event-related potentials
Time Frame
0 weeks, 12 weeks
Title
task-related EEG - n-back paradigm
Description
functional connectivity using graph theoretical measures, event-related potentials
Time Frame
0 weeks, 12 weeks
Title
functional MRI - resting-state
Description
cortical activity (BOLD)
Time Frame
0 weeks, 12 weeks, 24 weeks
Title
functional MRI - auditory oddball paradigm
Description
event-related fMRI
Time Frame
0 weeks, 12 weeks, 24 weeks
Other Pre-specified Outcome Measures:
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
Measure of anxiety and depression
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in Fatigue Scale for Motor and Cognitive functions (FSMC)
Description
Measure of fatigue in MS
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in Visual Analogue Scale (VAS)
Description
VAS on the impact of perceived cognitive symptoms on daily life
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in 36-Item Short Form Survey (SF-36)
Description
Measure of quality of life Only Dutch-speaking participants
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in Multiple Sclerosis Impact Scale-29 (MSIS-29)
Description
Measure of quality of life in MS Only Dutch-speaking participants
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in Multiple Sclerosis-59 (SEP-59)
Description
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.
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in Cognitive Leisure Activity Scale (CLAS)
Description
Measure of baseline cognitive activities
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks
Title
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Description
Measure of baseline physical activities
Time Frame
0 weeks, 12 weeks, 24 weeks, 64 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine Van Laethem
Phone
+32 2 629 10 45
Email
Delphine.Van.Laethem@vub.be
First Name & Middle Initial & Last Name or Official Title & Degree
Guy Nagels
Phone
+32 2 477 64 10
Email
guy.nagels@vub.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Nagels
Organizational Affiliation
Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Nagels
Facility Name
National MS Center Melsbroek
City
Melsbroek
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel D'Haeseleer

12. IPD Sharing Statement

Citations:
PubMed Identifier
36104820
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.
Results Reference
derived

Learn more about this trial

Cognitive-motor Telerehabilitation in MS

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