Investigating how different electrical waveforms affect comfort in ear stimulation
How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
This study tests whether different types of electrical stimulation on the ear feel more comfortable for healthy adults aged 18 to 80.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Coral Gables, Florida) |
| Trial ID | NCT06614933 on ClinicalTrials.gov |
What this trial studies
This research focuses on the effects of various forms of transcutaneous auricular vagus nerve stimulation (taVNS) applied to the ear. The study aims to assess how different waveforms influence the comfort and tolerability of this gentle electrical stimulation. Participants will receive either biphasic or monophasic taVNS to determine which is more effective and comfortable. The research will involve healthy adults aged 18 to 80 who can communicate in English.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 80 who can speak English.
Not a fit: Patients with chronic pain, unstable medical conditions, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods of non-invasive stimulation for various therapeutic applications.
How similar studies have performed: While the specific approach of this study may be novel, similar studies on vagus nerve stimulation have shown promising results in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Coral Gables, Florida
- University of Miami, Plumer Building — Coral Gables, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Marlon Wong, PT, PhD — University of Miami
- Study coordinator: Marlon Wong, DPT, PhD
- Email: mwong2@miami.edu
- Phone: 305-243-8117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.