Motor Training and White Matter in Multiple Sclerosis (MS)
This study has been terminated.
Sponsor:
Hasselt University
Collaborators:
Katholieke Universiteit Leuven
Provinciale Hogeschool Limburg
Information provided by (Responsible Party):
Koen Cuypers, Hasselt University
ClinicalTrials.gov Identifier:
NCT01279655
First received: January 18, 2011
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Multiple Sclerosis |
Device: tDCS Behavioral: Bimanual Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Hasselt University:
Primary Outcome Measures:
- Change in White Matter [ Time Frame: Baseline, immediately after and 3 weeks after the intervention ] [ Designated as safety issue: Yes ]Diffusion Tensor Imaging (DTI) T1 structural scan Fluid-attenuated inversion recovery Scan (FLAIR) Magnetization Transfer Imaging (MTI)
Secondary Outcome Measures:
- Change in Quality of Life [ Time Frame: Baseline, immediately after and 3 weeks after the intervention ] [ Designated as safety issue: No ]Questionnaire
- Blood sample [ Time Frame: After the end of the study ] [ Designated as safety issue: Yes ]BDNF Genotyping
| Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2013 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: 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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 68 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279655
Locations
| Belgium | |
| Hasselt University (BIOMED) | |
| Diepenbeek, Limburg, Belgium, 3590 | |
Sponsors and Collaborators
Hasselt University
Katholieke Universiteit Leuven
Provinciale Hogeschool Limburg
Investigators
| Principal Investigator: | Raf Meesen, Phd | Hasselt University |
More Information
No publications provided
| Responsible Party: | Koen Cuypers, Drs, Hasselt University |
| ClinicalTrials.gov Identifier: | NCT01279655 History of Changes |
| Other Study ID Numbers: | MECU2012-001 |
| Study First Received: | January 18, 2011 |
| Last Updated: | September 11, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013