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Cognitive-motor Telerehabilitation in MS

Study acronym: CoMoTeMS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: May 31, 2027 to Aug 31, 2027v6
  2. Primary completion date: May 2024 to May 31, 2027
    • Study completion date: May 2025 to May 31, 2027
    • Secondary endpoints: 16 to 14
    • Collaborators revised (2)
    v5
  3. Secondary endpoints: 14 to 16v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2022 to Sep 1, 2022
    v3
  5. Start date: Jul 2022 to Sep 2022
    • Secondary endpoints: 11 to 14
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05355389
Lead Sponsor Universitair Ziekenhuis Brussel
Collaborators: National MS Center Melsbroek, Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
Conditions
(from sponsor)		 Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov