Motor Training and White Matter in Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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In the current study the researchers will firstly investigate whether a bimanual coordination training protocol (20 min/day, for 8 consecutive weeks) correlates with changes in white matter architecture and improved upper-limb functionality in patients with multiple sclerosis. Secondly, the researchers predict that motor learning is more efficient when it is combined with anodal transcranial direct current (tDCS) stimulation on the left primary motor cortex.

Official Title
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The Influence of a tDCS Combined Long-term Motor Training Program on Structural White Matter Changes in the Brain, Functionality and Psychological Outcome Measures in Multiple Sclerosis.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: tDCS
* Behavioral: Bimanual Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Expanded Disability Status Scale (EDSS) scores between 2 and 6.5 Stable MS (no relapse during the last 3 months before study onset) age: between 18 and 68 years Exclusion Criteria: Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication. Standard TMS/tDCS and MRI exclusion criteria (safety questionnaires)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS and training<br>Transcranial Direct current stimulation (tDCS) is applied together with a bimanual learning task. tDCS is delivered through two gel-sponge electrodes (eldith DC Stimulator, neuroConn GmbH, Ilmenau, Germany) embedded in a saline-soaked solution. tDCS will be applied for 20 min, with a current intensity of 1mA. | Device: tDCS<br>* 20 min, 1mA, 8 weeks (5 days a week, 20 min a day)<br>* Other names: eldith, neuroConn, serial 0118;Behavioral: Bimanual Training<br>* The training program consisted of a bimanual etch-a-sketch task. By rotating two wheels subjects have to match a line presented on the screen with the cursor. 8 weeks (5 days a week, 20 min a day)<br>|
| No Intervention: Control<br>No intervention is applied | |
| Placebo Comparator: Sham tDCS + Training<br>The training consists of a bimanual training task. tDCS is only applied for a few seconds and will than be ramped-down. | Device: tDCS<br>* 20 min, 1mA, 8 weeks (5 days a week, 20 min a day)<br>* Other names: eldith, neuroConn, serial 0118;Behavioral: Bimanual Training<br>* The training program consisted of a bimanual etch-a-sketch task. By rotating two wheels subjects have to match a line presented on the screen with the cursor. 8 weeks (5 days a week, 20 min a day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in White Matter | Diffusion Tensor Imaging (DTI) T1 structural scan Fluid-attenuated inversion recovery Scan (FLAIR) Magnetization Transfer Imaging (MTI) | Baseline, immediately after and 3 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Questionnaire | Baseline, immediately after and 3 weeks after the intervention | 
| Blood sample | BDNF Genotyping | After the end of the study |