NCT05966922

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

18 days

First QC Date

July 13, 2023

Last Update Submit

August 19, 2023

Conditions

Electricity; EffectsHeart Arrhythmia

Keywords

Transcutaneous electrical nerve stimulationNeuromuscular electrical stimulationHeart rhythmheart rate variability

Outcome Measures

Primary Outcomes (2)

  • Heart rate

    RR interval will be calculated

    up to 2 weeks

  • Heart rate variability

    Variability of RR interval will be calculated

    up to 2 weeks

Study Arms (1)

Electrical Stimulation

EXPERIMENTAL

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

Procedure: Transcutaneous Electrical Stimulation

Interventions

Transcutaneous Electrical StimulationPROCEDURE

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.

Electrical Stimulation

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adult volunteer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Physical Therapy Training and Research Hospital

Istanbul, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • İLHAN KARACAN, MD, Prof

    İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This study will be conducted in an experimental study design.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 1, 2023

Study Start

July 13, 2023

Primary Completion

July 31, 2023

Study Completion

August 1, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

TU(1)