Motor Training and White Matter in Multiple Sclerosis (MS)

Not Applicable

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Device: tDCS; Behavioral: Bimanual Training

• Registration Number: NCT01279655
• Lead Sponsor: Hasselt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Primary Completion: 2011-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-12
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS + Training	Bimanual Training	The training consists of a bimanual training task. tDCS is only applied for a few seconds and will than be ramped-down.
Sham tDCS + Training	tDCS	The training consists of a bimanual training task. tDCS is only applied for a few seconds and will than be ramped-down.
tDCS and training	tDCS	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.
tDCS and training	Bimanual Training	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	Baseline, immediately after and 3 weeks after the intervention	Questionnaire
Blood sample	After the end of the study	BDNF Genotyping

Trial Locations

Locations (1)

Hasselt University (BIOMED); 🇧🇪 Diepenbeek, Limburg, Belgium