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CompletedNCT03982472Updated Jun 14, 2019

TENS Impact Heart Rate Via Vagus Activity

An interventional study of transcutaneous electric stimulation in Transcutaneous Electric Nerve Stimulation and Heart Rate, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2019-06-14.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jul 2017, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Transcutaneous Electric Nerve Stimulation
  • Heart Rate

Keywords

  • heart rate
  • TENS
  • vagus nerve
03

In context

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

healthy adult

Exclusion criteria

Exclusion Criteria:

hypertension diabetes heart diseases neurological diseases othe medical problem

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    TENS right side

    TENS stimulation at the right side

    Other: transcutaneous electric stimulation

  • Experimental
    TENS left side

    TENS stimulation at the left side

    Other: transcutaneous electric stimulation

  • No intervention
    sham stimulation

    Sham stimulation

Interventions

  • Othertranscutaneous electric stimulation

    transcutaneous current with an amplitude around ten to hundred milliampere was applied topically to subjects

06

What researchers measure

Primary outcomes

  1. heart rate

    TENS stimulation modified HR

    Time frame: 5 min

07

Study locations

1 site
  • Taipei Medical University
    Taipei, Taiwan
08

References and documents

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 29716843 ↗
  • Brock 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 27957782 ↗
  • Connor 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 22380853 ↗
  • Hsieh 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 ↗

Individual participant data

Plan to share: Undecided — After our results have been published

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03982472
Lead sponsor
Taipei Medical University
Responsible party
Tzer-Bin Lin (Professor, Taipei Medical University) — Principal investigator
First posted
Jun 11, 2019
Start date
Jul 22, 2017
Primary completion
Jul 21, 2018
Completion
Jul 21, 2018
Last update
Jun 14, 2019

Study contacts

Tzer-Bin Lin, PhD
principal investigator · Taipei Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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