Transcutaneous Electrical Stimulation & Sinoatrial Node Function (TENS&HR)
Primary Purpose
Electricity; Effects, Heart Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcutaneous Electrical Stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Electricity; Effects focused on measuring Transcutaneous electrical nerve stimulation, Neuromuscular electrical stimulation, Heart rhythm, heart rate variability
Eligibility Criteria
Inclusion Criteria: Healthy young adult volunteer Exclusion Criteria: Pregnancy Alcohol or drug abuse, Any medication with potential effects on the cardiovascular system
Sites / Locations
- İstanbul Physical Therapy Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electrical Stimulation
Arm Description
Electrical Stimulation and Sham will be delivered transcutaneously in random consecutive sessions
Outcomes
Primary Outcome Measures
Heart rate
RR interval will be calculated
Heart rate variability
Variability of RR interval will be calculated
Secondary Outcome Measures
Full Information
NCT ID
NCT05966922
First Posted
July 13, 2023
Last Updated
August 19, 2023
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05966922
Brief Title
Transcutaneous Electrical Stimulation & Sinoatrial Node Function
Acronym
TENS&HR
Official Title
Effects of Transcutaneous Electrical Stimulation on the Sinoatrial Node Function
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electricity; Effects, Heart Arrhythmia
Keywords
Transcutaneous electrical nerve stimulation, Neuromuscular electrical stimulation, Heart rhythm, heart rate variability
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will be conducted in an experimental study design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrical Stimulation
Arm Type
Experimental
Arm Description
Electrical Stimulation and Sham will be delivered transcutaneously in random consecutive sessions
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous Electrical Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart rate
Description
RR interval will be calculated
Time Frame
up to 2 weeks
Title
Heart rate variability
Description
Variability of RR interval will be calculated
Time Frame
up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy young adult volunteer
Exclusion Criteria:
Pregnancy
Alcohol or drug abuse,
Any medication with potential effects on the cardiovascular system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İLHAN KARACAN, MD, Prof
Organizational Affiliation
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
Official's Role
Study Chair
Facility Information:
Facility Name
İstanbul Physical Therapy Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34180
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Electrical Stimulation & Sinoatrial Node Function
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