Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation

December 4, 2024 updated by: Virginia Commonwealth University

A Pilot Study of Auricular Microstimulation to Determine if it Improves Vagal Modulation

This study is to determine if the auricular microstimulator produces the expected increase in HRV.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aim of this proposal is to determine if utilizing an affordable tool like microstimulation utilizing a transcutaneous electric nerve stimulator (TENS) unit and applying the stimulation to the ear though an ear clip does improve vagal modulation. This can be easily done at home by utilizing the microstimulation for 2 hours/day and measuring vagal modulation before and after. Previous research investigating this had participants use the unit for 2 hours as well (Chelimsky et al., 2019), however the data from this study was inconclusive, and therefore this study aims to demonstrate effectiveness of the unit usage on heart rate variability (HRV).

Although functional gastrointestinal disorders (FGID) affect 10%-20% of children and adolescents. 1-3 the pathophysiology remains unknown. The multiple current hypotheses include visceral hypersensitivity, altered brain-gut connections, dysbiosis, genetic and epigenetic factors, and increased gut permeability among others. 4 Since the vagus nerve links the brain to the gut, many studies of adult subjects have evaluated the cardiovagal modulation in this group of disorders. The cardiovagal modulation can be measured by heart rate variability (HRV). HRV evaluates the heart rate fluctuation over a period of time. HRV is considered a reliable tool to look at parasympathetic function, baroreflex function, and parasympathetic to sympathetic balance.5, 6 High-frequency (hf) HRV is a marker of vagal modulation. The low-frequency (lf) HRV probably reflects cardiac autonomic outflow from the baroreflex or parasympathetic regulation, rather than sympathetic modulation, although this is still being discussed.6, 7

A meta-analysis of adult subjects with irritable bowel syndrome (IBS) showed decreased cardiovagal modulation.8 One study compared children aged 7-10 years of age with functional abdominal pain or IBS to healthy subjects. They found no difference in cardiovagal and cardiac sympathetic modulation.9 However, a study of young adolescents with different chronic pain syndromes, including chronic abdominal pain, showed decreased cardiovagal modulation.10 These findings are similar to those in many adult syndromes with chronic pain, such as chronic pelvic pain,11 complex regional pain syndrome,12 fibromyalgia,13 and chronic neck pain.14

Although future research would aim to investigate vagal modulation in those specifically with FGID, for preliminary data purposes we are testing the unit's effects on heart rate variability regardless of having/not having an FGID diagnosis.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female
  • 12 - 21 years old
  • Either diagnosed OR not diagnosed with chronic idiopathic nausea, functional abdominal pain, dyspepsia and/or irritable bowel syndrome.
  • English speaking

Exclusion Criteria:

  • Patients who are unable to stand upright during the heart rate variability recording
  • Patients with a known bleeding disorder
  • Patients with swollen, infected, inflamed, or other skin eruptions on outer ear
  • Patients with epilepsy
  • Patients with any implanted cardiac pacemaker or defibrillator
  • Patients with serious arterial circulatory problems in the lower limbs
  • Patients with abdominal or inguinal hernia
  • Patients who are pregnant
  • Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.
  • Requires new medication during the 4 weeks of the study that may affect the gastrointestinal symptoms, vagal modulation or immune response.
  • Practices over 1 hour of aerobic activity a day
  • Daily practice of abdominal breathing (yoga)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FGID
Patients with a FGID
Device: TENS Unit
Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
Experimental: Non-FGID
Patients without a FGID
Device: TENS Unit
Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in High-frequency Heart Rate Variability (hfHRV) at 4 Weeks
Time Frame: Assessed at baseline and 4 weeks.

Determine if microstimulation over a 4 week period results in improvement in hfHRV power.

Average hfHRV power was calculated at baseline and 4 weeks. The change in average hfHRV power in milliseconds squared from baseline to 4 weeks was calculated for each participant. The average change for each group is reported.
Assessed at baseline and 4 weeks.
Rate of Compliance With Daily TENS Usage
Time Frame: Assessed daily for duration of study (4 weeks) via self-report recording journal.

Determine the compliance rate of adolescents utilizing a microstimulator.

Compliance rate calculated as number of minutes unit was used (summed from all self-report daily recording journals) divided by 3360 (the total number of minutes the unit could have been used if the participant used it for 2 hours daily for 4 weeks). The rate average for each group is reported.
Assessed daily for duration of study (4 weeks) via self-report recording journal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Gisela Chelimsky, MD, VCU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Actual)

June 4, 2024

Study Completion (Actual)

June 4, 2024

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20025635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymized information may be shared to other researchers for future relevant projects.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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