Cognitive-motor Telerehabilitation in MS

Официальное название

Cognitive-motor Telerehabilitation in Multiple Sclerosis

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Change in Digit span backwards [Срок оценки: 0 weeks, 12 weeks, 24 weeks, 64 weeks]

Вторичные конечные точки (12)

• Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) [Срок оценки: 0 weeks, 12 weeks, 24 weeks, 64 weeks]
• Change in Corsi backwards [Срок оценки: 0 weeks, 12 weeks, 24 weeks, 64 weeks]
• Change in Expanded Disability Status Scale (EDSS) [Срок оценки: 0 weeks, 12 weeks, 24 weeks, 64 weeks]
• Change in 6-Minute Walk Test (6MWT) [Срок оценки: 0 weeks, 12 weeks, 24 weeks, 64 weeks]
• Change in 25-Foot Walk Test (25FWT) [Срок оценки: 0 weeks, 12 weeks, 24 weeks, 64 weeks]
• Change in 9-Hole Peg Test (9HPT) [Срок оценки: 0 weeks, 12 weeks, 24 weeks, 64 weeks]
• MRI T1 3D BRAVO scan [Срок оценки: 0 weeks, 12 weeks, 24 weeks]
• MRI T2 FLAIR 3D Cube scan [Срок оценки: 0 weeks, 12 weeks, 24 weeks]
• Diffusion weighted image (DWI) [Срок оценки: 0 weeks, 12 weeks, 24 weeks]
• Synthetic MRI [Срок оценки: 0 weeks, 12 weeks, 24 weeks]
• resting-state EEG [Срок оценки: 0 weeks, 12 weeks]
• task-related EEG - auditory oddball paradigm [Срок оценки: 0 weeks, 12 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 2 центра

• Universitair Ziekenhuis Brussel — Brussels
• National MS Center Melsbroek — Melsbroek

Публикации

• 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

Идентификаторы

NCT: NCT05355389 · CoMoTeMS · 1SD5322N

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗