Multiple SclerosisNCT01279655
Motor Training and White Matter in Multiple Sclerosis (MS)
A study testing tDCS and Bimanual Training in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- tDCS and Bimanual Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Multiple Sclerosis
- Being tested
- tDCS, Bimanual Training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called eldith, neuroConn, serial 0118
20 min, 1mA, 8 weeks (5 days a week, 20 min a day)
Bimanual TrainingBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: tDCS; Behavioral: 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. Receives: Device: tDCS; Behavioral: Bimanual Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in White Matter
Diffusion Tensor Imaging (DTI) T1 structural scan Fluid-attenuated inversion recovery Scan (FLAIR) Magnetization Transfer Imaging (MTI)
Measured: Baseline, immediately after and 3 weeks after the intervention
Secondary outcomes (2)
Change in Quality of Life
Questionnaire
Measured: Baseline, immediately after and 3 weeks after the intervention
Blood sample
BDNF Genotyping
Measured: After the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Provinciale Hogeschool Limburg
- Responsible party
- Principal investigator, Koen Cuypers, Hasselt University
- Investigators
- Raf Meesen, Phd, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279655
- Sponsor's protocol ID
- MECU2012-001
- Status last verified
- Sep 2012
- First submitted
- 18 Jan 2011
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01279655
- Acronym / sponsor ID
- MECU2012-001
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- KU Leuven, Provinciale Hogeschool Limburg
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2013 (estimated)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS and training | Experimental | Device: tDCS, Behavioral: Bimanual TrainingTranscranial 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. |
| Control | No intervention | –No intervention is applied |
| Sham tDCS + Training | Placebo comparator | Device: tDCS, Behavioral: Bimanual TrainingThe training consists of a bimanual training task. tDCS is only applied for a few seconds and will than be ramped-down. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: eldith, neuroConn, serial 011820 min, 1mA, 8 weeks (5 days a week, 20 min a day) | Device | Sham tDCS + Training, tDCS and training |
| Bimanual TrainingThe 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) | Behavioural | Sham tDCS + Training, tDCS and training |
Primary outcome
Change in White Matter
Time frame: Baseline, immediately after and 3 weeks after the intervention
Diffusion Tensor Imaging (DTI) T1 structural scan Fluid-attenuated inversion recovery Scan (FLAIR) Magnetization Transfer Imaging (MTI)
2 secondary outcomes
Change in Quality of Life
Time frame: Baseline, immediately after and 3 weeks after the intervention
Blood sample
Time frame: After the end of the study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raf Meesen, Phd principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Bimanual Training in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in White Matter (time frame: Baseline, immediately after and 3 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2012.