Motor Training and White Matter in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01279655
• Other study ID #: MECU2012-001
• Status: Terminated
• Phase: N/A
• First received: January 18, 2011
• Last updated: September 11, 2012
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: September 2012
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• tDCS
20 min, 1mA, 8 weeks (5 days a week, 20 min a day)

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)

Locations

Country	Name	City	State
Belgium	Hasselt University (BIOMED)	Diepenbeek	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	Katholieke Universiteit Leuven, Provinciale Hogeschool Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change in Quality of Life	Questionnaire	Baseline, immediately after and 3 weeks after the intervention	No
Secondary	Blood sample	BDNF Genotyping	After the end of the study	Yes