Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

Bahçeşehir University

Status: Completed

Conditions: Autonomic Nervous System Imbalance

Treatments: Device: Transcutaneous Auricular Vagus Nerve Stimulation; Device: Transcutaneous Auricular Trigeminal Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06730165

Study0009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Transcutaneous Auricular Vagus Nerve Stimulation

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Transcutaneous Auricular Trigeminal Nerve Stimulation

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous Auricular Trigeminal Nerve Stimulation

Sham Transcutaneous Auricular Vagus Nerve Stimulation

Sham Comparator group

Description:

Sham Transcutaneous Auricular Vagus Nerve Stimulation, The device is switched on but the current intensity is off, Duration: 20 minutes

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Sham Transcutaneous Auricular Trigeminal Nerve Stimulation

Sham Comparator group

Description:

Sham Transcutaneous Auricular Trigeminal Nerve Stimulation, The device is switched on but the current intensity is off, Duration: 20 minutes

Treatment:

Device: Transcutaneous Auricular Trigeminal Nerve Stimulation