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

JRCT ID: jRCT1032230440

Registered date:09/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Not targeting any disease.
• Date of first enrollment: 07/11/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Transcutaneous Electric Nerve Stimulation

Outcome(s)

Primary Outcome

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 Outcome: Sleep data from brainwaves, Apple Watch, and Fitbit.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Tainaka Kazuki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development