Cortical ExcitabilityNCT01740843
The Effect of tDCS on Motor Performance and Cortical Excitability
A study testing transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator) in people with Cortical Excitability and Motor Performance, run by Hasselt University.
Trial summary
In this study the effect of tDCS intensity on motor performance and corticospinal (CS) excitability is evaluated. The investigators expect that a positive relationship between current intensity and motor performance/CS excitability. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cortical Excitability, Motor Performance, tDCS
- 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jun 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
Who cannot join
- Contraindications for tDCS/TMS
- TMS measurements have to be possible
About this study
In this study the effect of tDCS intensity on motor performance and corticospinal (CS) excitability is evaluated. The investigators expect that a positive relationship between current intensity and motor performance/CS excitability.
- Conditions
- Cortical Excitability, Motor Performance, tDCS
- 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 is fixed on the primary cortex and the cathode will be fixed on the contralateral supraorbital region.
| Study group | Role | What they receive |
|---|---|---|
| Low intensity anodal tDCS | Active comparator | tDCS will be administered for 10 min at 1mA Receives: Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator) |
| High intensity anodal tDCS | Experimental | tDCS will be administered for 10 min at 2.5mA Receives: Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator) |
| Sham tDCS | Sham comparator | Sham will be administered for 10 min at 0 mA 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.
Change in motor performance
motor performance is assessed using different reaction time paradigms (simple reaction time, choice reaction time). This is done at baseline and immediately after the intervention (30 min after baseline)
Measured: Baseline and POST (30 min after baseline) intervention
Change in cortical excitability
Cortical excitability is measured using trancranial magnetic stimulation (TMS) measuring muscle evoked potentials (MEPs) at baseline and POST (30 min after baseline).
Measured: Baseline 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 startAug 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical ExcitabilityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- NCT01740843
- Sponsor's protocol ID
- MECU2012-004
- Status last verified
- Feb 2014
- First submitted
- 26 Nov 2012
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of tDCS on Motor Performance and Cortical Excitability
- ClinicalTrials.gov ID
- NCT01740843
- Acronym / sponsor ID
- MECU2012-004
- Conditions
- Cortical Excitability, Motor Performance, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (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.
In this study the effect of tDCS intensity on motor performance and corticospinal (CS) excitability is evaluated. The investigators expect that a positive relationship between current intensity and motor performance/CS excitability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low intensity anodal tDCS | Active comparator | Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)tDCS will be administered for 10 min at 1mA |
| High intensity anodal tDCS | Experimental | Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)tDCS will be administered for 10 min at 2.5mA |
| Sham tDCS | Sham comparator | Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)Sham will be administered for 10 min at 0 mA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (2 listed)
- Contraindications for tDCS/TMS
- TMS measurements have to be possible
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 is fixed on the primary cortex and the cathode will be fixed on the contralateral supraorbital region. | Device | High intensity anodal tDCS, Low intensity anodal tDCS, Sham tDCS |
Primary outcome
Change in motor performance
Time frame: Baseline and POST (30 min after baseline) intervention
motor performance is assessed using different reaction time paradigms (simple reaction time, choice reaction time). This is done at baseline and immediately after the intervention (30 min after baseline)
Change in cortical excitability
Time frame: Baseline and POST (30 min after baseline) intervention
Cortical excitability is measured using trancranial magnetic stimulation (TMS) measuring muscle evoked potentials (MEPs) at baseline and POST (30 min after baseline).
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 25 Feb 2014.
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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 Cortical Excitability and Motor Performance, 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 1 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: finished, as of the sponsor's last update on 25 Feb 2014. 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?
Change in motor performance (time frame: Baseline and POST (30 min after baseline) intervention). The study lists 2 primary outcomes in all. 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 25 Feb 2014; AzTrials last refreshed its copy on 7 Nov 2026.