Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1

NCT06381102 | Completed Results FDA Device

• 1 other identifier: 20240134
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Tolerability Measured by Tolerability Questionnaire

  Tolerability will be assessed with a questionnaire with scores ranging from 0 -10 (with 0 being no irritation or discomfort and 10 being the worst possible irritation or discomfort) for irritation from tingling/tickling/pricking during taVNS.

  3 hours

• Tolerability Measured by Self-report

  The number of participants who reported mild pain with the intervention.

  3 hours

Secondary Outcomes (1)

• Change in Heart Rate Variability (HRV)

  Baseline and 3 hours

Study Arms (2)

taVNS 30/30 group

EXPERIMENTAL

Participants in the group taVNS 30/30 will be in this group for up to 3 hours.

Device: transcutaneous auricular vagus nerve stimulation 30/30

taVNS 10/10 group

EXPERIMENTAL

Participants in the group taVNS 10/10 will be in this group for up to 3 hours.

Device: transcutaneous auricular vagus nerve stimulation 10/10

Interventions

transcutaneous auricular vagus nerve stimulation 30/30 DEVICE

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a 30 second on and 30 second off, for 1 hour, in-person.

taVNS 30/30 group

transcutaneous auricular vagus nerve stimulation 10/10 DEVICE

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a 10 second on and 10 second off, for 1 hour, in-person.

taVNS 10/10 group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages of 18-80 years
• English speaking (must be able to consent and complete the interviews in English)

You may not qualify if:

• chronic pain (average intensity \>2/10 on 0-10 scale, for longer than 3 months)
• acute pain of intensity greater than 3/10
• chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
• any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
• pregnancy
• currently taking Buprenorphine or recently stopped taking (within 1 month)
• presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
• implants in the head or neck, cochlear implants, or pacemaker
• head or neck metastasis or recent ear trauma
• history of epilepsy
• history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Results Point of Contact

• Title: Marlon Wong, Associate Professor of Clinical
• Organization: University of Miami

mwong2@miami.edu

3052842670

Study Officials

• Marlon Wong, DPT, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: April 13, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)