TENS Impact Heart Rate Via Vagus Activity

Heart Rate Clinical Trial

Official title:

Shoulder Transcutaneous Electric Nerve Stimulation Decelerates Heart Rhythm of Subjects Via Potentiating Vagal Tone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982472
• Other study ID #: TENS-HR
• Status: Completed
• Phase: N/A
• Start date: July 22, 2017
• Est. completion date: July 21, 2018

Study information

• Verified date: June 2019
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 21, 2018
• Est. primary completion date: July 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

healthy adult

Exclusion Criteria:

hypertension diabetes heart diseases neurological diseases othe medical problem

Related Conditions & MeSH terms

• Heart Rate
• Transcutaneous Electric Nerve Stimulation

Intervention

Other:
• transcutaneous electric stimulation
transcutaneous current with an amplitude around ten to hundred milliampere was applied topically to subjects

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

Brock C, Brock B, Aziz Q, Møller 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate	TENS stimulation modified HR	5 min