Transcutaneous Electric Nerve StimulationNCT03982472
TENS Impact Heart Rate Via Vagus Activity
A study testing transcutaneous electric stimulation in people with Transcutaneous Electric Nerve Stimulation and Heart Rate, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Transcutaneous electric nerve stimulation (TENS) is widely used for the treatment of adhesive capsulitis, nevertheless, its potential impact on heart physiology has not been well established. The investigator explored if TENS at shoulder region affect heart rhythm and the machinery involved. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Transcutaneous Electric Nerve Stimulation, Heart Rate
- What is being tested?
- transcutaneous electric stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jul 2017to 21 Jul 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy adult
Who cannot join
- hypertension diabetes heart diseases neurological diseases othe medical problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shoulder Transcutaneous Electric Nerve Stimulation Decelerates Heart Rhythm of Subjects Via Potentiating Vagal Tone
Transcutaneous electric nerve stimulation (TENS) is widely used for the treatment of adhesive capsulitis, nevertheless, its potential impact on heart physiology has not been well established.
The investigator explored if TENS at shoulder region affect heart rhythm and the machinery involved.
Subjects were stratified into groups received sham stimulation (TENS-S) and TENS on either the right (TENS-R) or left (TENS-L) shoulder. A built-in waveform for treating adhesive capsulitis with a maximal tolerable intensity below the pain threshold was applied to subjects form a commercial TENS equipment for 5 min. The electrocardiogram (ECG) and heart rate (HR) were continuously recorded and the ECG was off-line transferred into power spectrum for analysis.
Read the detailed description
Study design This study complied with the Declaration of Helsinki, and all protocols were approved by the ethics committee of Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. All the participants gave written informed consent before experiments. 32 subjects (20-51 years old) were included in the statistical analysis. Participants were eligible if they have cardiovascular illnesses, major mental conditions, or severe inflammation. Participants were allocated to groups that received sham stimulation (TENS-S) and TENS on the right and left shoulder (TENS-R and TENS-L, respectively).
ECG and HR recordings Using a monitor lead, electrocardiogram (ECG) was recorded through electrodes connected to a recording system with a sampling rate of 5,000 samples/sec. The ECG and the HR calculated by a built-in rate meter were continuously recorded and displayed on a monitor. For TENS caused marked artifacts in ECG tracings, HR derived from ECG were confirmed off-line by manual examination.
TENS stimulation To mimicking clinical scenarios, a commercial TENS equipment was used throughout this study. A built-in waveform recommended for treating capsulitis in the user's manual was used for stimulation (triple pulses with 1 ms pulse durations separated by a 1 ms intervals were ramps up and down between 2 to 10 Hz within 20 sec for 3 min and then ramps up from 10 to 200 Hz within 20 sec and kept at 200 Hz for 2 min; supplementary data 1). The current intensity was adjusted to the maximal tolerance level below the pain threshold. A pair of stimulating electrode was placed in the front of the should at the level of the sternal notch at about 2 finger-width from the mid-clavicle line, and a pair of dispersive electrode was placed at the back of shoulder opposite to the stimulating electrodes. Participants kept a stationary supine position and was asked to refrain from moving during recording. Before the stimulation, there was an equilibrium period for at least 10 min, and then the recording started. TENS was turned on for 5 min at 5 min after the baseline recording, and the recording continued until 10 min after the offset of stimulation. Parameters of the sham stimulation was identical to TENS stimulation on the right shoulder excepting the equipment was left un-powered.
- Being tested
- transcutaneous electric stimulation
- Keywords
- heart rate, TENS, vagus nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electric stimulationOther
transcutaneous current with an amplitude around ten to hundred milliampere was applied topically to subjects
| Study group | Role | What they receive |
|---|---|---|
| TENS right side | Experimental | TENS stimulation at the right side Receives: Other: transcutaneous electric stimulation |
| TENS left side | Experimental | TENS stimulation at the left side Receives: Other: transcutaneous electric stimulation |
| sham stimulation | No intervention | Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
TENS stimulation modified HR
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start22 Jul 2017
- Primary completion21 Jul 2018
- Study completion21 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transcutaneous Electric Nerve StimulationStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Difference of group was compared between groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzer-Bin Lin, Taipei Medical University
- Investigators
- Tzer-Bin Lin, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982472
- Sponsor's protocol ID
- TENS-HR
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After our results have been published
Publications
Badran BW, Mithoefer OJ, Summer CE, LaBate NT, Glusman CE, Badran AW, DeVries WH, Summers PM, Austelle CW, McTeague LM, Borckardt JJ, George MS. Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. Brain Stimul. 2018 Jul-Aug;11(4):699-708. doi: 10.1016/j.brs.2018.04.004. Epub 2018 Apr 6.
PubMed 29716843Brock C, Brock B, Aziz Q, Moller HJ, Pfeiffer Jensen M, Drewes AM, Farmer AD. Transcutaneous cervical vagal nerve stimulation modulates cardiac vagal tone and tumor necrosis factor-alpha. Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12999. Epub 2016 Dec 12.
PubMed 27957782Connor DE Jr, Nixon M, Nanda A, Guthikonda B. Vagal nerve stimulation for the treatment of medically refractory epilepsy: a review of the current literature. Neurosurg Focus. 2012 Mar;32(3):E12. doi: 10.3171/2011.12.FOCUS11328.
PubMed 22380853Hsieh CM, Lin WC, Peng HY, Chen HC, Ho YC, Li CJ, Wu XG, Chung JY, Lee SD, Lin TB. Shoulder transcutaneous electric nerve stimulation decreases heart rate via potentiating vagal tone. Sci Rep. 2021 Sep 27;11(1):19168. doi: 10.1038/s41598-021-98690-6.
PubMed 34580404
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Transcutaneous Electric Nerve Stimulation Decelerates Heart Rhythm of Subjects Via Potentiating Vagal Tone
- ClinicalTrials.gov ID
- NCT03982472
- Acronym / sponsor ID
- TENS-HR
- Keywords
- heart rate, TENS, vagus nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 22 Jul 2017 (actual)
- Primary completion
- 21 Jul 2018 (actual)
- Study completion
- 21 Jul 2018 (actual)
- First posted
- 11 Jun 2019 (actual)
- 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.
Transcutaneous electric nerve stimulation (TENS) is widely used for the treatment of adhesive capsulitis, nevertheless, its potential impact on heart physiology has not been well established.
The investigator explored if TENS at shoulder region affect heart rhythm and the machinery involved.
Subjects were stratified into groups received sham stimulation (TENS-S) and TENS on either the right (TENS-R) or left (TENS-L) shoulder. A built-in waveform for treating adhesive capsulitis with a maximal tolerable intensity below the pain threshold was applied to subjects form a commercial TENS equipment for 5 min. The electrocardiogram (ECG) and heart rate (HR) were continuously recorded and the ECG was off-line transferred into power spectrum for analysis.
Detailed description
Study design This study complied with the Declaration of Helsinki, and all protocols were approved by the ethics committee of Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. All the participants gave written informed consent before experiments. 32 subjects (20-51 years old) were included in the statistical analysis. Participants were eligible if they have cardiovascular illnesses, major mental conditions, or severe inflammation. Participants were allocated to groups that received sham stimulation (TENS-S) and TENS on the right and left shoulder (TENS-R and TENS-L, respectively).
ECG and HR recordings Using a monitor lead, electrocardiogram (ECG) was recorded through electrodes connected to a recording system with a sampling rate of 5,000 samples/sec. The ECG and the HR calculated by a built-in rate meter were continuously recorded and displayed on a monitor. For TENS caused marked artifacts in ECG tracings, HR derived from ECG were confirmed off-line by manual examination.
TENS stimulation To mimicking clinical scenarios, a commercial TENS equipment was used throughout this study. A built-in waveform recommended for treating capsulitis in the user's manual was used for stimulation (triple pulses with 1 ms pulse durations separated by a 1 ms intervals were ramps up and down between 2 to 10 Hz within 20 sec for 3 min and then ramps up from 10 to 200 Hz within 20 sec and kept at 200 Hz for 2 min; supplementary data 1). The current intensity was adjusted to the maximal tolerance level below the pain threshold. A pair of stimulating electrode was placed in the front of the should at the level of the sternal notch at about 2 finger-width from the mid-clavicle line, and a pair of dispersive electrode was placed at the back of shoulder opposite to the stimulating electrodes. Participants kept a stationary supine position and was asked to refrain from moving during recording. Before the stimulation, there was an equilibrium period for at least 10 min, and then the recording started. TENS was turned on for 5 min at 5 min after the baseline recording, and the recording continued until 10 min after the offset of stimulation. Parameters of the sham stimulation was identical to TENS stimulation on the right shoulder excepting the equipment was left un-powered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Difference of group was compared between groups
| Arm | Type | Receives |
|---|---|---|
| TENS right side | Experimental | Other: transcutaneous electric stimulationTENS stimulation at the right side |
| TENS left side | Experimental | Other: transcutaneous electric stimulationTENS stimulation at the left side |
| sham stimulation | No intervention | –Sham stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adult
Key exclusion criteria (1 listed)
- hypertension diabetes heart diseases neurological diseases othe medical problem
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 electric stimulationtranscutaneous current with an amplitude around ten to hundred milliampere was applied topically to subjects | Other | TENS left side, TENS right side |
Primary outcome
heart rate
Time frame: 5 min
TENS stimulation modified HR
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 14 Jun 2019.
- Background: PubMed 29716843Badran BW, Mithoefer OJ, Summer CE, LaBate NT, Glusman CE, Badran AW, DeVries WH, Summers PM, Austelle CW, McTeague LM, Borckardt JJ, George MS. Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. Brain Stimul. 2018 Jul-Aug;11(4):699-708. doi: 10.1016/j.brs.2018.04.004. Epub 2018 Apr 6.
- Background: PubMed 27957782Brock C, Brock B, Aziz Q, Moller HJ, Pfeiffer Jensen M, Drewes AM, Farmer AD. Transcutaneous cervical vagal nerve stimulation modulates cardiac vagal tone and tumor necrosis factor-alpha. Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12999. Epub 2016 Dec 12.
- Background: PubMed 22380853Connor DE Jr, Nixon M, Nanda A, Guthikonda B. Vagal nerve stimulation for the treatment of medically refractory epilepsy: a review of the current literature. Neurosurg Focus. 2012 Mar;32(3):E12. doi: 10.3171/2011.12.FOCUS11328.
- Derived from this study: PubMed 34580404Hsieh CM, Lin WC, Peng HY, Chen HC, Ho YC, Li CJ, Wu XG, Chung JY, Lee SD, Lin TB. Shoulder transcutaneous electric nerve stimulation decreases heart rate via potentiating vagal tone. Sci Rep. 2021 Sep 27;11(1):19168. doi: 10.1038/s41598-021-98690-6.
- Individual participant dataSharing planned: Undecided. After our results have been published
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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.
Tzer-Bin Lin, PhD principal investigator
Taipei Medical 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 transcutaneous electric stimulation in people with Transcutaneous Electric Nerve Stimulation and Heart Rate, run by Taipei Medical 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 1 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 14 Jun 2019. 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?
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?
heart rate (time frame: 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982472, which also lists 4 linked publications.
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 14 Jun 2019.