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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Transcutaneous Auricular Trigeminal Nerve Stimulation | Active Comparator | Transcutaneous auricular trigeminal nerve stimulation, Frequency: 25 Hertz, Duration: 20 minutes |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation | Device | Stimulation of the vagus nerve through the tragus and concha in the ear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | 5 minutes of heart rate variability was measured. | Pre-intervention and immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and Diastolic Blood Pressure | Systolic and diastolic blood pressure was measured with an electronic blood pressure monitor. | Pre-intervention and immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yavuz Ozoran, Prof. | Dean of the Health Sciences Faculty | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avrasya University | Trabzon | Ortahisar | 61000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33355897 | Background | 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. | |
| 25614179 | Background |
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| Transcutaneous Auricular Trigeminal Nerve Stimulation | Device | Stimulation of the trigeminal nerve via the auriculotemporal nerve with a clip electrode from the upper auricle |
|
| 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. |
| 18164486 | 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. |
| 41143755 | Derived | 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. 2026 Jun;29(4):588-596. doi: 10.1016/j.neurom.2025.09.312. Epub 2025 Oct 27. |