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Motor Training and White Matter in Multiple Sclerosis (MS)

This study has been terminated.
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014