Transcutaneous Electrical Stimulation & Sinoatrial Node Function (TENS&HR)

• ClinicalTrials.gov Identifier: NCT05966922
• Recruitment Status: Completed
• First Posted: August 1, 2023
• Last Update Posted: August 22, 2023
• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Information provided by (Responsible Party): Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Tracking Information

• First Submitted Date: July 13, 2023
• First Posted Date: August 1, 2023
• Last Update Posted Date: August 22, 2023
• Actual Study Start Date: July 13, 2023
• Actual Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 20, 2023)

• Heart rate [ Time Frame: up to 2 weeks ]
  RR interval will be calculated
• Heart rate variability [ Time Frame: up to 2 weeks ]
  Variability of RR interval will be calculated

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Transcutaneous Electrical Stimulation & Sinoatrial Node Function
• Official Title: Effects of Transcutaneous Electrical Stimulation on the Sinoatrial Node Function
• 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).

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This study will be conducted in an experimental study design.

Masking: None (Open Label)
Primary Purpose: Prevention

Condition

• Electricity; Effects
• Heart Arrhythmia

Intervention

Procedure: Transcutaneous 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.

Study Arms

Experimental: Electrical Stimulation

Electrical Stimulation and Sham will be delivered transcutaneously in random consecutive sessions

Intervention: Procedure: Transcutaneous Electrical Stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 19, 2023): 34
• Original Estimated Enrollment (submitted: July 20, 2023): 30
• Actual Study Completion Date: August 1, 2023
• Actual Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy young adult volunteer

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT05966922
• Other Study ID Numbers: ISTPMRTENS1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: İLHAN KARACAN, MD, Prof; İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

• PRS Account: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Verification Date: August 2023