Motor Training and White Matter in Multiple Sclerosis (MS)

NCT ID: NCT01279655

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

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

Bimanual Training

Intervention Type BEHAVIORAL

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)

Control

No intervention is applied

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type PLACEBO_COMPARATOR

tDCS

Intervention Type DEVICE

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

Bimanual Training

Intervention Type BEHAVIORAL

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)

Interventions

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tDCS

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

Intervention Type DEVICE

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)

Intervention Type BEHAVIORAL

Other Intervention Names

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eldith, neuroConn, serial 0118

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Provinciale Hogeschool Limburg

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Koen Cuypers

Drs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raf Meesen, Phd

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

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Hasselt University (BIOMED)

Diepenbeek, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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MECU2012-001

Identifier Type: -

Identifier Source: org_study_id