Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1

How Does the Length of Pulse Trains and Pulse Intervals Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: transcutaneous auricular vagus nerve stimulation 30/30; Device: transcutaneous auricular vagus nerve stimulation 10/10

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: taVNS 30/30 group; 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; 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.
Experimental: taVNS 10/10 group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate Variability (HRV)	HRV will be measured with an H10 chest strap device. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS measured in milliseconds.	Baseline and 3 hours

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Marlon Wong, DPT, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20240134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No