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

University of Miami30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Biphasic transcutaneous auricular vagus nerve stimulationDEVICE

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 stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

University of Miami, Plumer Building

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

Tolerability Measured by Tolerability Questionnaire

Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort) to 10 (worst pain imaginable) for comfort.

Time frame: Up to 3 hours

Tolerability Measured by Self Report

Tolerability will be assessed by self-report using semi-structured interviews conducted at the end of each study visit. Participants will report whether they experienced mild pain during each transcutaneous auricular vagus nerve stimulation (taVNS) protocol. The outcome measure is the count of participants who reported mild pain, as collected during interviews conducted at the end of each visit.

Time frame: Up to 3 hours

Secondary Outcomes

Change in Heart Rate Variability (HRV)

Heart rate variability (HRV) will be measured using an H10 chest strap device and expressed in milliseconds. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS.

Time frame: Baseline and up to 3 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.