NCT06614933

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-06-07
• Completion: 2025-06-07
• First posted: 2024-09-26
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study