How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

NCT ID: NCT06614933

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-06-07

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: DOUBLE

Study Groups

Biphasic followed by monophasic taVNS group

Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours.

Group Type: EXPERIMENTAL

Biphasic transcutaneous auricular vagus nerve stimulation

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 biphasic current, continuous at 25 Hz, for 1 hour, in-person.

Monophasic transcutaneous auricular vagus nerve stimulation

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 monophasic current, with a 50% duty cycle at 25 Hz, for 1-hour, in-person.

Monophasic followed by biphasic taVNS group

Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.

Group Type: ACTIVE_COMPARATOR

Biphasic transcutaneous auricular vagus nerve stimulation

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 biphasic current, continuous at 25 Hz, for 1 hour, in-person.

Monophasic transcutaneous auricular vagus nerve stimulation

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 monophasic current, with a 50% duty cycle at 25 Hz, for 1-hour, in-person.

Interventions

Biphasic transcutaneous auricular vagus nerve stimulation

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 biphasic current, continuous at 25 Hz, for 1 hour, in-person.

Intervention Type: DEVICE

Monophasic transcutaneous auricular vagus nerve stimulation

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 monophasic current, with a 50% duty cycle at 25 Hz, 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

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marlon Wong, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami, Plumer Building

Coral Gables, Florida, United States

Countries

United States

Other Identifiers

20240796

Identifier Type: -

Identifier Source: org_study_id