Skip to content

Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

Comparison of the Effect of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation on Heart Rate Variability

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06730165
Enrollment
80
Registered
2024-12-12
Start date
2024-03-03
Completion date
2024-09-10
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Nervous System Imbalance

Keywords

Vagus Nerve Stimulations, Trigeminal Nerve Stimulations

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.

Interventions

DEVICETranscutaneous Auricular Vagus Nerve Stimulation

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

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

Sponsors

Bahçeşehir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate VariabilityPre-intervention and immediately after the intervention5 minutes of heart rate variability was measured.

Secondary

MeasureTime frameDescription
Systolic and Diastolic Blood PressurePre-intervention and immediately after the interventionSystolic and diastolic blood pressure was measured with an electronic blood pressure monitor.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026