Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

NCT06730165 | Completed DMC

• 1 other identifier: Study0009
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autonomic Nervous System Imbalance

Keywords

Vagus Nerve Stimulations; Trigeminal Nerve Stimulations

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  5 minutes of heart rate variability was measured.

  Pre-intervention and immediately after the intervention

Secondary Outcomes (1)

• Systolic and Diastolic Blood Pressure

  Pre-intervention and immediately after the intervention

Study Arms (4)

Transcutaneous Auricular Vagus Nerve Stimulation

ACTIVE COMPARATOR

Transcutaneous vagus nerve stimulation through the tragus and concha in the ear, Frequency: 25 Hertz, Duration: 20 minutes

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Transcutaneous Auricular Trigeminal Nerve Stimulation

ACTIVE COMPARATOR

Transcutaneous auricular trigeminal nerve stimulation, Frequency: 25 Hertz, Duration: 20 minutes

Device: Transcutaneous Auricular Trigeminal Nerve Stimulation

Sham Transcutaneous Auricular Vagus Nerve Stimulation

SHAM COMPARATOR

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

Sham Transcutaneous Auricular Trigeminal Nerve Stimulation

SHAM COMPARATOR

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

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

Stimulation of the vagus nerve through the tragus and concha in the ear

Sham Transcutaneous Auricular Vagus Nerve Stimulation; Transcutaneous Auricular Vagus Nerve Stimulation

Transcutaneous Auricular Trigeminal Nerve Stimulation DEVICE

Stimulation of the trigeminal nerve via the auriculotemporal nerve with a clip electrode from the upper auricle

Sham Transcutaneous Auricular Trigeminal Nerve Stimulation; Transcutaneous Auricular Trigeminal Nerve Stimulation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Avrasya University

Trabzon, Ortahisar, 61000, Turkey (Türkiye)

Location

Related Publications (4)

• Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23.

  PMID: 33355897 BACKGROUND

• Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.

  PMID: 25614179 BACKGROUND

• Milby AH, Halpern CH, Baltuch GH. Vagus nerve stimulation for epilepsy and depression. Neurotherapeutics. 2008 Jan;5(1):75-85. doi: 10.1016/j.nurt.2007.10.071.

  PMID: 18164486 BACKGROUND

• Percin A, Ozden AV, Yenisehir S, Albayrak HE. Autonomic Effects of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation: A Randomized, Sham-Controlled, and Single-Blind Study. Neuromodulation. 2025 Oct 27:S1094-7159(25)01038-4. doi: 10.1016/j.neurom.2025.09.312. Online ahead of print.

  PMID: 41143755 DERIVED

Study Officials

• Yavuz Ozoran, Prof.

  Dean of the Health Sciences Faculty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 12, 2024
• Study Start: March 3, 2024
• Primary Completion: April 1, 2024
• Study Completion: September 10, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)