Cognitive-motor Telerehabilitation in MS

NCT05355389 | Recruiting DMC

• 2 other identifiers: CoMoTeMS1SD5322N
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; cognitive rehabilitation; cognitive-motor rehabilitation; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Digit span backwards

  Measure of working memory

  0 weeks, 12 weeks, 24 weeks, 64 weeks

Secondary Outcomes (14)

• Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)

  0 weeks, 12 weeks, 24 weeks, 64 weeks

• Change in Corsi backwards

  0 weeks, 12 weeks, 24 weeks, 64 weeks

• Change in Expanded Disability Status Scale (EDSS)

  0 weeks, 12 weeks, 24 weeks, 64 weeks

• Change in 6-Minute Walk Test (6MWT)

  0 weeks, 12 weeks, 24 weeks, 64 weeks

• Change in 25-Foot Walk Test (25FWT)

  0 weeks, 12 weeks, 24 weeks, 64 weeks

Other Outcomes (8)

• Change in Hospital Anxiety and Depression Scale (HADS)

  0 weeks, 12 weeks, 24 weeks, 64 weeks

• Change in Fatigue Scale for Motor and Cognitive functions (FSMC)

  0 weeks, 12 weeks, 24 weeks, 64 weeks

• Change in Visual Analogue Scale (VAS)

  0 weeks, 12 weeks, 24 weeks, 64 weeks

Study Arms (3)

Cognitive-motor training group

EXPERIMENTAL

Behavioral: Cognitive training; Behavioral: Motor training

Cognitive training group

ACTIVE COMPARATOR

Behavioral: Cognitive training

Motor training group

ACTIVE COMPARATOR

Behavioral: Motor training

Interventions

Cognitive training BEHAVIORAL

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.

Also known as: BrainStim

Cognitive training group; Cognitive-motor training group

Motor training BEHAVIORAL

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.

Cognitive-motor training group; Motor training group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• National MS Center Melsbroek: collaborator
• Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek): collaborator

Study Sites (2)

Universitair Ziekenhuis Brussel

Brussels, Belgium

RECRUITING

National MS Center Melsbroek

Melsbroek, Belgium

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Guy Nagels

  Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delphine Van Laethem

CONTACT

+32 2 629 10 45; Delphine.Van.Laethem@vub.be

Guy Nagels

CONTACT

+32 2 477 64 10; guy.nagels@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to either the cognitive-motor, the cognitive or the motor telerehabilitation group, stratified by baseline activity level and cognition.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 2, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

BE (2)