Transcutaneous Nerve StimulationNCT02115841
Effect of Transcutaneous Nerve Stimulation on Primary Motor Cortex to Modulate Cortical Excitability and Hemodynamic Response During Implicit Motor Learning: A TMS and NIRS Study
A study testing "Enraf-Nonius" Muscle stimulator in people with Transcutaneous Nerve Stimulation, run by Chang Gung University at 1 site in Taiwan.
Trial summary
Noninvasive brain stimulation was recently gradually be emphasized. The electrical current applied on scalp can effective modulate cortical excitability. Forms of Stimulation included transcranial direct current stimulation(tDCS) and transcranial alternating stimulation(tACS). Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcutaneous Nerve Stimulation
- What is being tested?
- "Enraf-Nonius" Muscle stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Jul 2014
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health Adult
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Ya-Ju Chang, PhD, 88632118800 ext. 5515, yjchang@mail.cgu.edu.tw
About this study
Noninvasive brain stimulation was recently gradually be emphasized. The electrical current applied on scalp can effective modulate cortical excitability. Forms of Stimulation included transcranial direct current stimulation(tDCS) and transcranial alternating stimulation(tACS). tDCS had been proved the effect of cortical excitability modulation. The polarization effect of direct current stimulation can modulation specific brain area and enhance motor performance. tACS was still controversial about the effect on cortical excitability. Previous study show that the frequency dependent excitatory or inhibitory effect on cortex. The possible mechanism was to affect brain oscillation status by provided different frequency of stimulation. Transcutaneous nerve stimulation (TENS) was common used on management of chronic pain. Peripheral nerve stimulation can enhance pain or sensory evoked potential was noted. Effect of low frequency TENS on central nervous is unknown.
- Conditions
- Transcutaneous Nerve Stimulation
- Being tested
- "Enraf-Nonius" Muscle stimulator
- Keywords
- Transcutaneous Nerve Stimulation, serial reaction time task, functional near infrared spectroscopy, transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Enraf-Nonius" Muscle stimulatorDevice
Also called Transcutaneous nerve stimulation
The order 15Hz TENS stimulation session and sham stimulation session will also be randomized.
| Study group | Role | What they receive |
|---|---|---|
| E1 | Experimental | Experiment 1 will measure the cortical excitability change after TENS intervention. Receives: Device: "Enraf-Nonius" Muscle stimulator |
| E2 | Experimental | Experiment 2 will measures implicit sequential motor task performance and cortical hemodynamic response using near infrared spectroscopy (NIRS) during motor execution. Cortical excitability will also be measured contemporary Receives: Device: "Enraf-Nonius" Muscle stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential
Use single-pulse TMS to assess Motor evoked potential change.
Measured: Baseline,0 minute,30 minutes,60 minutes.
Intracortical inhibition & Intracortical facilitation
Use paired-pulse TMS to record pre-test and post-test change.
Measured: Baseline,0 minute,30 minutes,60 minutes.
Blood oxygen dependent level
Use Near-infrared spectroscopy to record pre-test, in experiment, and post-test change
Measured: Baseline,in experiment,0 minute,30 minutes,60 minutes.
Implicit sequential motor task performance
Change of Measure of Learning curve.
Measured: Baseline,in experiment,0 minute,30 minutes,60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Nerve StimulationStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115841
- Sponsor's protocol ID
- 102-2266A3
- Status last verified
- Apr 2014
- First submitted
- 27 Mar 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Nerve Stimulation on Primary Motor Cortex to Modulate Cortical Excitability and Hemodynamic Response During Implicit Motor Learning: A TMS and NIRS Study
- ClinicalTrials.gov ID
- NCT02115841
- Acronym / sponsor ID
- 102-2266A3
- Conditions
- Transcutaneous Nerve Stimulation
- Keywords
- Transcutaneous Nerve Stimulation, serial reaction time task, functional near infrared spectroscopy, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 16 Apr 2014 (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.
Noninvasive brain stimulation was recently gradually be emphasized. The electrical current applied on scalp can effective modulate cortical excitability. Forms of Stimulation included transcranial direct current stimulation(tDCS) and transcranial alternating stimulation(tACS). tDCS had been proved the effect of cortical excitability modulation. The polarization effect of direct current stimulation can modulation specific brain area and enhance motor performance. tACS was still controversial about the effect on cortical excitability. Previous study show that the frequency dependent excitatory or inhibitory effect on cortex. The possible mechanism was to affect brain oscillation status by provided different frequency of stimulation. Transcutaneous nerve stimulation (TENS) was common used on management of chronic pain. Peripheral nerve stimulation can enhance pain or sensory evoked potential was noted. Effect of low frequency TENS on central nervous is unknown.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E1 | Experimental | Device: "Enraf-Nonius" Muscle stimulatorExperiment 1 will measure the cortical excitability change after TENS intervention. |
| E2 | Experimental | Device: "Enraf-Nonius" Muscle stimulatorExperiment 2 will measures implicit sequential motor task performance and cortical hemodynamic response using near infrared spectroscopy (NIRS) during motor execution. Cortical excitability will also be measured contemporary |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Health Adult
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| "Enraf-Nonius" Muscle stimulatorAlso: Transcutaneous nerve stimulationThe order 15Hz TENS stimulation session and sham stimulation session will also be randomized. | Device | E1, E2 |
Primary outcome
Motor evoked potential
Time frame: Baseline,0 minute,30 minutes,60 minutes.
Use single-pulse TMS to assess Motor evoked potential change.
Intracortical inhibition & Intracortical facilitation
Time frame: Baseline,0 minute,30 minutes,60 minutes.
Use paired-pulse TMS to record pre-test and post-test change.
Blood oxygen dependent level
Time frame: Baseline,in experiment,0 minute,30 minutes,60 minutes.
Use Near-infrared spectroscopy to record pre-test, in experiment, and post-test change
Implicit sequential motor task performance
Time frame: Baseline,in experiment,0 minute,30 minutes,60 minutes.
Change of Measure of Learning curve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Enraf-Nonius" Muscle stimulator in people with Transcutaneous Nerve Stimulation, run by Chang Gung University at 1 site in Taiwan.
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 0 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: status not confirmed, as of the sponsor's last update on 16 Apr 2014. 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 Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor evoked potential (time frame: Baseline,0 minute,30 minutes,60 minutes.). The study lists 4 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 16 Apr 2014.