NCT01279655

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

January 18, 2011

Last Update Submit

September 11, 2012

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change in Quality of Life

    Baseline, immediately after and 3 weeks after the intervention

  • Blood sample

    After the end of the study

Study Arms (3)

tDCS and training

EXPERIMENTAL

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: tDCSBehavioral: Bimanual Training

Control

NO INTERVENTION

No intervention is applied

Sham tDCS + Training

PLACEBO COMPARATOR

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

Device: tDCSBehavioral: Bimanual Training

Interventions

tDCSDEVICE

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

Also known as: eldith, neuroConn, serial 0118
Sham tDCS + TrainingtDCS and training
Bimanual TrainingBEHAVIORAL

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)

Sham tDCS + TrainingtDCS and training

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University (BIOMED)

Diepenbeek, Limburg, 3590, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Raf Meesen, Phd

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

May 1, 2013

Last Updated

September 12, 2012

Record last verified: 2012-09

Locations

BE(1)