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Transcutaneous Electrical Stimulation & Sinoatrial Node Function

Effects of Transcutaneous Electrical Stimulation on the Sinoatrial Node Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05966922
Acronym
TENS&HR
Enrollment
34
Registered
2023-08-01
Start date
2023-07-13
Completion date
2023-08-01
Last updated
2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electricity; Effects, Heart Arrhythmia

Keywords

Transcutaneous electrical nerve stimulation, Neuromuscular electrical stimulation, Heart rhythm, heart rate variability

Brief summary

Transcutaneous electrical stimulation (TES) is used in clinical practice to diagnose or treat a diverse range of medical conditions for over a century. Although the benefits of TES are well known, its potential side effects on the heart have not been convincingly clarified. This study will test whether TES has any effect on the sinoatrial node (SAN).

Detailed description

It was hypothesized that: 1) TES has effects indirectly via peripheral afferents or directly on the SAN, and 2) TES causes a change in the R-R interval (HRV). The aim of this study was to test these hypotheses. This research protocol will have three phases: first, the effect of a single electrical pulse on heart rate variability (HRV) will be examined in Experiment I. The effects of conventional TENS and acupuncture-like TENS on HRV will be also investigated in Experiment II. Finally, the effect of time and rest on the HRV will be tested in Experiment III. Subjects will be in a sitting position with 90-degree flexion at the elbow and supination of the hand during electrical stimulation. A pair of square (4 x 4 cm), self-adhesive, pre-gelled skin electrodes will be used for stimulation. The electrodes will be placed over the flexor aspect of the right forearm. Three-lead electrocardiogram (ECG) recording will be obtained to determine the change of HRV during rest and electrical stimulation sessions. The participant's ECG data will be continuously captured by noninvasive sensors \[self-adhesive pre-gelled Ag/AgCl surface electromyography (sEMG) electrodes, Redline® Istanbul, Türkiye\] transmitted through a data acquisition system. The main outcome variable is the heart rhythm. In this context, electrical stimulus-related QRS wave and RR interval change (heart rate variability) will be examined. The possible direct effect of an electrical stimulus on the appearance of the QRS wave will be investigated in the time domain using the Peristimulus time histogram and the Waveform average technique. ECG data will be analyzed using a software package (Cambridge Electronic Designs, Cambridge, UK).

Interventions

PROCEDURETranscutaneous Electrical Stimulation

Electrical Stimulation and a sham will be administered through the skin in random consecutive sessions in a study group. A single monophasic square electrical pulse and transcutaneous electrical nerve stimulation will be applied to the forearm volar aspect.

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

This study will be conducted in an experimental study design.

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy young adult volunteer

Exclusion criteria

* Pregnancy * Alcohol or drug abuse, * Any medication with potential effects on the cardiovascular system

Design outcomes

Primary

MeasureTime frameDescription
Heart rateup to 2 weeksRR interval will be calculated
Heart rate variabilityup to 2 weeksVariability of RR interval will be calculated

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026