Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

Bahçeşehir University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

Conditions

Autonomic Nervous System Imbalance

Interventions

Transcutaneous Auricular Vagus Nerve StimulationDEVICE

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

Transcutaneous Auricular Trigeminal Nerve StimulationDEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Avrasya University

Trabzon, Ortahisar, Turkey (Türkiye)

Outcomes

Primary Outcomes

Heart Rate Variability

5 minutes of heart rate variability was measured.

Time frame: Pre-intervention and immediately after the intervention

Secondary Outcomes

Systolic and Diastolic Blood Pressure

Systolic and diastolic blood pressure was measured with an electronic blood pressure monitor.

Time frame: Pre-intervention and immediately after the intervention

Data from ClinicalTrials.gov

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