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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05966922
Recruitment Status : Completed
First Posted : August 1, 2023
Last Update Posted : August 22, 2023
Sponsor:
Information provided by (Responsible Party):
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Electricity; Effects Heart Arrhythmia Procedure: Transcutaneous Electrical Stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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
Official Title: Effects of Transcutaneous Electrical Stimulation on the Sinoatrial Node Function
Actual Study Start Date : July 13, 2023
Actual Primary Completion Date : July 31, 2023
Actual Study Completion Date : August 1, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Electrical Stimulation
Electrical Stimulation and Sham will be delivered transcutaneously in random consecutive sessions
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Heart rate [ Time Frame: up to 2 weeks ]
    RR interval will be calculated

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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy young adult volunteer

Exclusion Criteria:

  • Pregnancy
  • Alcohol or drug abuse,
  • Any medication with potential effects on the cardiovascular system
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05966922


Locations
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Turkey
İstanbul Physical Therapy Training and Research Hospital
Istanbul, Turkey, 34180
Sponsors and Collaborators
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Investigators
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Study Chair: İLHAN KARACAN, MD, Prof İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
More Information
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Responsible Party: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05966922    
Other Study ID Numbers: ISTPMRTENS1
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: August 22, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital:
Transcutaneous electrical nerve stimulation
Neuromuscular electrical stimulation
Heart rhythm
heart rate variability
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes