Cognitive-motor Telerehabilitation in Multiple Sclerosis

RecruitingNot a drug-phase studyMS (type not specified)NCT05355389

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Cognitive training
  • Motor training

What it measured

Main measures

  • Change in Digit span backwards

    0 weeks, 12 weeks, 24 weeks, 64 weeks

    Thinking and memory

Other measures (14)

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

    0 weeks, 12 weeks, 24 weeks, 64 weeks

    Thinking and memory
  • Change in Corsi backwards

    0 weeks, 12 weeks, 24 weeks, 64 weeks

    Thinking and memory
  • Change in Expanded Disability Status Scale (EDSS)

    0 weeks, 12 weeks, 24 weeks, 64 weeks

    Disability progression
  • Change in 6-Minute Walk Test (6MWT)

    0 weeks, 12 weeks, 24 weeks, 64 weeks

    Walking and mobility
  • Change in 25-Foot Walk Test (25FWT)

    0 weeks, 12 weeks, 24 weeks, 64 weeks

    Walking and mobility
  • Change in 9-Hole Peg Test (9HPT)

    0 weeks, 12 weeks, 24 weeks, 64 weeks

    Disability progressionArm and hand function
  • MRI T1 3D BRAVO scan

    0 weeks, 12 weeks, 24 weeks

    MRI lesions
  • MRI T2 FLAIR 3D Cube scan

    0 weeks, 12 weeks, 24 weeks

    MRI lesions
  • Diffusion weighted image (DWI)

    0 weeks, 12 weeks, 24 weeks

    MRI lesionsNerve conduction tests
  • Synthetic MRI

    0 weeks, 12 weeks, 24 weeks

    MRI lesions

Who could take part

MS (type not specified) · 18 to 65

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Sept 2022

    2. Main results due

      Aug 2027

    3. Finished

      Aug 2027

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