Anodal tDCSNCT01740830
The Effect of Anodal tDCS on Motor Learning in Multiple Sclerosis
A study testing Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator) in people with Anodal tDCS and Recruitment Curves, run by Hasselt University.
Trial summary
The current study investigates the effects of tDCS in patients with multiple sclerosis (MS). The investigators hypothesize that anodal tDCS will increase motor performance in patients with MS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anodal tDCS, Recruitment Curves
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Oct 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- male and female
Who cannot join
- relapse in the last 3 months
- when not suitable for tDCS (screening)
- if TMS measures can not be completed
About this study
The current study investigates the effects of tDCS in patients with multiple sclerosis (MS). The investigators hypothesize that anodal tDCS will increase motor performance in patients with MS.
- Conditions
- Anodal tDCS, Recruitment Curves
- Being tested
- Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator)Device
Also called Neuroconn DC-stimulator
The anode will be fixed over the primary motor cortex. The cathode will be fixed over the contralateral supraorbital region.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Active comparator | Not described Receives: Device: Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator) |
| Sham tDCS | Sham comparator | Not described Receives: Device: Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor performance on a unimanual sequence learning task
Patients were instructed to perform a unimanual sequence-learning task consisting of sequential finger presses. The following parameters were measured: Correct sequences/mean inter tap interval (ITI), percentage correct key presses/mean ITI, percentage correct sequences, percentage correct key presses, mean ITI, and mean correct sequences in the performance interval.
Measured: Baseline, during training and POST (30 min after baseline) intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anodal tDCSStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Cuypers, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740830
- Sponsor's protocol ID
- MECU2012-003
- Status last verified
- Jun 2013
- First submitted
- 26 Nov 2012
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anodal tDCS on Motor Learning in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01740830
- Acronym / sponsor ID
- MECU2012-003
- Conditions
- Anodal tDCS, Recruitment Curves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Dec 2012 (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.
The current study investigates the effects of tDCS in patients with multiple sclerosis (MS). The investigators hypothesize that anodal tDCS will increase motor performance in patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator) |
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years old
- male and female
Key exclusion criteria (3 listed)
- relapse in the last 3 months
- when not suitable for tDCS (screening)
- if TMS measures can not be completed
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator)Also: Neuroconn DC-stimulatorThe anode will be fixed over the primary motor cortex. The cathode will be fixed over the contralateral supraorbital region. | Device | Anodal tDCS, Sham tDCS |
Primary outcome
Motor performance on a unimanual sequence learning task
Time frame: Baseline, during training and POST (30 min after baseline) intervention
Patients were instructed to perform a unimanual sequence-learning task consisting of sequential finger presses. The following parameters were measured: Correct sequences/mean inter tap interval (ITI), percentage correct key presses/mean ITI, percentage correct sequences, percentage correct key presses, mean ITI, and mean correct sequences in the performance interval.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator) in people with Anodal tDCS and Recruitment Curves, run by Hasselt University.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Motor performance on a unimanual sequence learning task (time frame: Baseline, during training and POST (30 min after baseline) 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 4 Jun 2013.