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Motor Training and White Matter in Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis

Status

Terminated

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

tDCS

Bimanual Training

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Hasselt University (BIOMED)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Placebo Comparator

Arm Label

tDCS and training

Control

Sham tDCS + Training

Arm Description

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.

No intervention is applied

The training consists of a bimanual training task. tDCS is only applied for a few seconds and will than be ramped-down.

Outcomes

Primary Outcome Measures

Change in White Matter

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

Questionnaire

Blood sample

BDNF Genotyping

Full Information

NCT ID

NCT01279655

First Posted

January 18, 2011

Last Updated

September 11, 2012

Sponsor

Hasselt University

Collaborators

KU Leuven, Provinciale Hogeschool Limburg

1. Study Identification

Unique Protocol Identification Number

NCT01279655

Brief Title

Motor Training and White Matter in Multiple Sclerosis (MS)

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Terminated

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hasselt University

Collaborators

KU Leuven, Provinciale Hogeschool Limburg

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tDCS and training

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

No intervention is applied

Arm Title

Sham tDCS + Training

Arm Type

Placebo Comparator

Arm Description

The training consists of a bimanual training task. tDCS is only applied for a few seconds and will than be ramped-down.

Intervention Type

Device

Intervention Name(s)

tDCS

Other Intervention Name(s)

eldith, neuroConn, serial 0118

Intervention Description

20 min, 1mA, 8 weeks (5 days a week, 20 min a day)

Intervention Type

Behavioral

Intervention Name(s)

Bimanual Training

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change in White Matter

Description

Diffusion Tensor Imaging (DTI) T1 structural scan Fluid-attenuated inversion recovery Scan (FLAIR) Magnetization Transfer Imaging (MTI)

Time Frame

Baseline, immediately after and 3 weeks after the intervention

Secondary Outcome Measure Information:

Title

Change in Quality of Life

Description

Questionnaire

Time Frame

Baseline, immediately after and 3 weeks after the intervention

Title

Blood sample

Description

BDNF Genotyping

Time Frame

After the end of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raf Meesen, Phd

Organizational Affiliation

Hasselt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hasselt University (BIOMED)

City

Diepenbeek

State/Province

Limburg

ZIP/Postal Code

3590

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Motor Training and White Matter in Multiple Sclerosis (MS)

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