Motor Training and White Matter in Multiple Sclerosis (MS)

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.

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: tDCS; Behavioral: Bimanual Training

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Diepenbeek, Limburg, Belgium, 3590
      • Hasselt University (BIOMED)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS and 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.	Device: tDCS; 20 min, 1mA, 8 weeks (5 days a week, 20 min a day); Other Names: eldith, neuroConn, serial 0118; Behavioral: Bimanual Training; 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)
No Intervention: Control; No intervention is applied
Placebo Comparator: Sham tDCS + Training; The training consists of a bimanual training task. tDCS is only applied for a few seconds and will than be ramped-down.	Device: tDCS; 20 min, 1mA, 8 weeks (5 days a week, 20 min a day); Other Names: eldith, neuroConn, serial 0118; Behavioral: Bimanual Training; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: KU Leuven; Provinciale Hogeschool Limburg
• Investigators: Principal Investigator: Raf Meesen, Phd, Hasselt University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (Estimate): January 19, 2011

Study Record Updates

• Last Update Posted (Estimate): September 12, 2012
• Last Update Submitted That Met QC Criteria: September 11, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MECU2012-001