Electricity; EffectsTENS&HRNCT05966922
Transcutaneous Electrical Stimulation & Sinoatrial Node Function
A study testing Transcutaneous Electrical Stimulation in people with Electricity; Effects and Heart Arrhythmia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Electricity; Effects, Heart Arrhythmia
- What is being tested?
- Transcutaneous Electrical Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jul 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adult volunteer
Who cannot join
- Pregnancy
- Alcohol or drug abuse,
- Any medication with potential effects on the cardiovascular system
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Physical Therapy Training and Research Hospital
Istanbul, 34180
About this study
Official title: Effects of Transcutaneous Electrical Stimulation on the Sinoatrial Node Function
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).
Read the 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).
- Conditions
- Electricity; Effects, Heart Arrhythmia
- Being tested
- Transcutaneous Electrical Stimulation
- Keywords
- Transcutaneous electrical nerve stimulation, Neuromuscular electrical stimulation, Heart rhythm, heart rate variability
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical StimulationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Electrical Stimulation | Experimental | Electrical Stimulation and Sham will be delivered transcutaneously in random consecutive sessions Receives: Procedure: Transcutaneous Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
RR interval will be calculated
Measured: up to 2 weeks
Heart rate variability
Variability of RR interval will be calculated
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start13 Jul 2023
- Primary completion31 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electricity; EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will be conducted in an experimental study design.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- İLHAN KARACAN, MD, Prof, Study chair, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966922
- Sponsor's protocol ID
- ISTPMRTENS1
- Acronym
- TENS&HR
- Status last verified
- Aug 2023
- First submitted
- 13 Jul 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Stimulation on the Sinoatrial Node Function
- ClinicalTrials.gov ID
- NCT05966922
- Acronym / sponsor ID
- TENS&HR / ISTPMRTENS1
- Conditions
- Electricity; Effects, Heart Arrhythmia
- Keywords
- Transcutaneous electrical nerve stimulation, Neuromuscular electrical stimulation, Heart rhythm, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will be conducted in an experimental study design.
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation | Experimental | Procedure: Transcutaneous Electrical StimulationElectrical Stimulation and Sham will be delivered transcutaneously in random consecutive sessions |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young adult volunteer
Key exclusion criteria (3 listed)
- Pregnancy
- Alcohol or drug abuse,
- Any medication with potential effects on the cardiovascular system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical StimulationElectrical 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. | Procedure or surgery | Electrical Stimulation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İLHAN KARACAN, MD, Prof study chair
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Stimulation in people with Electricity; Effects and Heart Arrhythmia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.