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Exploratory Study on Establishing Optimal Stimulation Conditions through Transcutaneous Vagus Nerve Stimulation of the Auricular Concha

Exploratory Study on Establishing Optimal Stimulation Conditions through Transcutaneous Vagus Nerve Stimulation of the Auricular Concha

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032230440
Enrollment
20
Registered
2023-11-09
Start date
2023-11-07
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Not targeting any disease.

Interventions

Transcutaneous Electric Nerve Stimulation
taVNS

Sponsors

Tainaka Kazuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At the time of obtaining consent, healthy adults aged 18 years and older. 2. Individuals who, after receiving sufficient explanations regarding their participation in this study, provided written consent based on their own free will.

Exclusion criteria

Exclusion criteria: 1. Individuals with cardiovascular diseases at or above the level of the neck. 2. Individuals who have undergone vagus nerve transection surgery in the neck area. 3. Individuals who cannot provide informed consent or have declined to participate in this study. 4. Individuals with artificial cochlear implants, cardiac pacemakers, or implanted VNS devices. 5. Individuals with injuries to the auricular region. 6. Individuals deemed to be excluded by the principal investigator.

Design outcomes

Primary

MeasureTime frame
1. Stimulation parameters during taVNS at or below pain threshold, including stimulation sites (auricular concha, tragus, among others), pulse width (50, 100, 200, 300, 600 microsecond), and frequency (1, 5, 10, 25, 50, 100, 200 Hz). 2. Physiological data including electrocardiogram, heart rate variability, brain waves, eye movements, pupil diameter, and blood pressure changes. 3. Biochemical data of stress markers in saliva and oxidative stress markers in urine.

Secondary

MeasureTime frame
Sleep data from brainwaves, Apple Watch, and Fitbit.

Contacts

Public ContactKazuki Tainaka

Niigata University

kztainaka@bri.niigata-u.ac.jp+81-25-227-0900

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026