Transcutaneous Electrical Nerve StimulationNCT02077595
Effects of Transcutaneous Electrical Nerve Stimulation on Cortical Excitability in the Primary Motor Cortex in Healthy Adults
A study testing transcutaneous electrical nerve stimulation, TENS in people with Transcutaneous Electrical Nerve Stimulation, run by Chang Gung University at 1 site in Taiwan.
Trial summary
Recently, non-invasive brain stimulation has become a powerful tool in both basic research and clinical application. Among several non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have received the most attention. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcutaneous Electrical Nerve Stimulation
- What is being tested?
- transcutaneous electrical nerve stimulation, TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Jul 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Recently, non-invasive brain stimulation has become a powerful tool in both basic research and clinical application. Among several non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have received the most attention. About DC stimulation, the change of polarity could modulate the spontaneous neuronal activity and make effect on decision making, language, memory, sensory perception, and pain. In spite of that the concept of transcranial alternating current stimulation (tACS) is not novel, AC is relatively safe compared to DC, and researches have revealed that AC might potentially have the effect on the cortical excitability. However, there are still many areas about AC stimulation which remain unknown, such as mechanism, application, and potential influence on cortical excitability.
- Being tested
- transcutaneous electrical nerve stimulation, TENS
- Keywords
- transcutaneous electrical nerve stimulation, transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical nerve stimulation, TENSDevice
Then participants will receive stimulation for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 120Hz alternating current stimulation group | Active comparator | Not described Receives: Device: transcutaneous electrical nerve stimulation, TENS |
| 5Hz alternating current stimulation group | Active comparator | Not described Receives: Device: transcutaneous electrical nerve stimulation, TENS |
| sham alternating current stimulation group | Sham comparator | Not described Receives: Device: transcutaneous electrical nerve stimulation, TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential
measure of intracortical inhibition on abductor pollicis brevis by single-pulse TMS.
Measured: Baseline
Intracortical inhibition, ICI
Measure of changes in intracortical inhibition on abductor pollicis brevis by paired-pulse TMS.
Measured: Baseline,2 hours, 2.5 hours,and 3 hours
intracortical facilitation, ICF
Measure of changes in intracortical inhibition on abductor pollicis brevis by paired-pulse TMS.
Measured: Baseline,Baseline,2 hours, 2.5 hours,and 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
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
- NCT02077595
- Sponsor's protocol ID
- 101-3624B
- Status last verified
- Mar 2014
- First submitted
- 11 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation on Cortical Excitability in the Primary Motor Cortex in Healthy Adults
- ClinicalTrials.gov ID
- NCT02077595
- Acronym / sponsor ID
- 101-3624B
- Keywords
- transcutaneous electrical nerve stimulation, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Mar 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.
Recently, non-invasive brain stimulation has become a powerful tool in both basic research and clinical application. Among several non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have received the most attention. About DC stimulation, the change of polarity could modulate the spontaneous neuronal activity and make effect on decision making, language, memory, sensory perception, and pain. In spite of that the concept of transcranial alternating current stimulation (tACS) is not novel, AC is relatively safe compared to DC, and researches have revealed that AC might potentially have the effect on the cortical excitability. However, there are still many areas about AC stimulation which remain unknown, such as mechanism, application, and potential influence on cortical excitability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 120Hz alternating current stimulation group | Active comparator | Device: transcutaneous electrical nerve stimulation, TENS |
| 5Hz alternating current stimulation group | Active comparator | Device: transcutaneous electrical nerve stimulation, TENS |
| sham alternating current stimulation group | Sham comparator | Device: transcutaneous electrical nerve stimulation, TENS |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
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 |
|---|---|---|
| transcutaneous electrical nerve stimulation, TENSThen participants will receive stimulation for 20 minutes. | Device | 120Hz alternating current stimulation group, 5Hz alternating current stimulation group, sham alternating current stimulation group |
Primary outcome
Motor evoked potential
Time frame: Baseline
measure of intracortical inhibition on abductor pollicis brevis by single-pulse TMS.
Intracortical inhibition, ICI
Time frame: Baseline,2 hours, 2.5 hours,and 3 hours
Measure of changes in intracortical inhibition on abductor pollicis brevis by paired-pulse TMS.
intracortical facilitation, ICF
Time frame: Baseline,Baseline,2 hours, 2.5 hours,and 3 hours
Measure of changes in intracortical inhibition on abductor pollicis brevis by paired-pulse TMS.
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 Mar 2014.
Related trials for Transcutaneous Electrical Nerve Stimulation
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation, TENS in people with Transcutaneous Electrical 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: finished, as of the sponsor's last update on 4 Mar 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. 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 evoked potential (time frame: Baseline). The study lists 3 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 4 Mar 2014.