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Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

NCT ID: NCT06730165

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-03

Study Completion Date

2024-09-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autonomic Nervous System Imbalance

Keywords

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Vagus Nerve Stimulations Trigeminal Nerve Stimulations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transcutaneous Auricular Vagus Nerve Stimulation

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

Group Type ACTIVE_COMPARATOR

Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type DEVICE

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

Transcutaneous Auricular Trigeminal Nerve Stimulation

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

Group Type ACTIVE_COMPARATOR

Transcutaneous Auricular Trigeminal Nerve Stimulation

Intervention Type DEVICE

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

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

Group Type SHAM_COMPARATOR

Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type DEVICE

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

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

Group Type SHAM_COMPARATOR

Transcutaneous Auricular Trigeminal Nerve Stimulation

Intervention Type DEVICE

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

Interventions

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Transcutaneous Auricular Vagus Nerve Stimulation

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

Intervention Type DEVICE

Transcutaneous Auricular Trigeminal Nerve Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

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Alper Percin

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yavuz Ozoran, Prof.

Role: STUDY_CHAIR

Dean of the Health Sciences Faculty

Locations

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Avrasya University

Trabzon, Ortahisar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33355897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25614179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18164486 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41143755 (View on PubMed)

Other Identifiers

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Study0009

Identifier Type: -

Identifier Source: org_study_id