Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1

NCT ID: NCT06381102

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-13
• Study Completion Date: 2024-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

taVNS 30/30 group

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

Group Type: EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation 30/30

Intervention Type: 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 10/10 group

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

Group Type: EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation 10/10

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Marlon Wong

Associate Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marlon Wong, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20240134

Identifier Type: -

Identifier Source: org_study_id