Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

December 11, 2024 updated by: Alper Percin, Bahçeşehir University

Comparison of the Effect of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation on Heart Rate Variability

The aim of this study was to compare the results between transcutaneous auricular vagus nerve stimulation and trigeminal nerve stimulation with the results obtained from heart rate variability, pulse and blood pressure measurements and to reveal which method is more effective in autonomic nervous system neuromodulation.

Hypotheses of the study:

H0: Vagus nerve stimulation is more effective than trigeminal nerve simulation in terms of heart rate variability.

H1: Trigeminal nerve stimulation is more effective than vagus nerve simulation in terms of heart rate variability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, 80 healthy participants (40 males, 40 females) aged between 20-50 years were randomized (www.randomizer.org) into four groups by computer software. After randomisation, one group was received transcutaneous vagus nerve stimulation inside the ear, while the other group was received trigeminal nerve stimulation above the ear.The third group received sham transcutaneous vagus nerve stimulation and the fourth group received sham trigeminal nerve simulation. Heart rate variability, pulse rate and blood pressure measurements were performed to determine which stimulation method is more effective. Heart rate variability was analysed with Kubios HRV programme after the 5-minute short measurement method. SNS, PNS and Stress Index and LF, HF and LF/HF parameters were evaluated in heart rate variability sub-parameters.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Turkey
    • Ortahisar
      • Trabzon, Ortahisar, Turkey, 61000
        • Avrasya 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • To be 18 years of age or older,
  • Not having any acute or chronic disease.

Exclusion Criteria:

  • Having any acute or chronic disease,
  • Having previously undergone vagus nerve stimulation or trigeminal nerve stimulation.

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: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcutaneous Auricular Vagus Nerve Stimulation
Transcutaneous vagus nerve stimulation through the tragus and concha in the ear, Frequency: 25 Hertz, Duration: 20 minutes
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Stimulation of the vagus nerve through the tragus and concha in the ear
Active Comparator: Transcutaneous Auricular Trigeminal Nerve Stimulation
Transcutaneous auricular trigeminal nerve stimulation, Frequency: 25 Hertz, Duration: 20 minutes
Device: Transcutaneous Auricular Trigeminal Nerve Stimulation
Stimulation of the trigeminal nerve via the auriculotemporal nerve with a clip electrode from the upper auricle
Sham Comparator: Sham Transcutaneous Auricular Vagus Nerve Stimulation
Sham Transcutaneous Auricular Vagus Nerve Stimulation, The device is switched on but the current intensity is off, Duration: 20 minutes
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Stimulation of the vagus nerve through the tragus and concha in the ear
Sham Comparator: Sham Transcutaneous Auricular Trigeminal Nerve Stimulation
Sham Transcutaneous Auricular Trigeminal Nerve Stimulation, The device is switched on but the current intensity is off, Duration: 20 minutes
Device: Transcutaneous Auricular Trigeminal Nerve Stimulation
Stimulation of the trigeminal nerve via the auriculotemporal nerve with a clip electrode from the upper auricle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: Pre-intervention and immediately after the intervention
5 minutes of heart rate variability was measured.
Pre-intervention and immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and Diastolic Blood Pressure
Time Frame: Pre-intervention and immediately after the intervention
Systolic and diastolic blood pressure was measured with an electronic blood pressure monitor.
Pre-intervention and immediately after the intervention

Collaborators and Investigators

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

Sponsor

Bahçeşehir University

Investigators

  • Study Chair: Yavuz Ozoran, Prof., Dean of the Health Sciences Faculty

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)

March 3, 2024

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

September 10, 2024

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Estimated)

December 12, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Study0009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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