Clinical trial NCT06730165: Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation
Official title: Comparison of the Effect of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation on Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Nervous System Imbalance
Keywords: Vagus Nerve Stimulations
Trigeminal Nerve Stimulations
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heart Rate Variability
timeFrame: Pre-intervention and immediately after the intervention
Secondary outcomes:
measure: Systolic and Diastolic Blood Pressure
timeFrame: Pre-intervention and immediately after the intervention
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Avrasya University
state: Ortahisar
Study officials:
affiliation: Dean of the Health Sciences Faculty
name: Yavuz Ozoran, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.