A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- Mayo Clinic
- Study ID
- NCT07420803
- Status
- Recruiting
Conditions
- Chronic Dizziness
- Persistent Postural Perceptual Dizziness
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sham Device — OTHERThe sham control uses the same stimulation devices as the active group, but with modified electrodes that do not emit electrical current. Instead, they produce a mechanical vibration or clicking sensation that mimics the feeling of stimulation without delivering current to the skin.
- Auricular transcutaneous vagus nerve stimulation — OTHERThe Parasym AVNT is a noninvasive, transcutaneous auricular vagus nerve stimulator (tVNS) designed to deliver low-level electrical stimulation to the auricular branch of the vagus nerve through the skin of the outer ear. The stimulator produces mild, pulsed electrical currents typically ranging from 0.1 to 5.0 milliampere (mA) at frequencies between 20-30 Hz and pulse widths of approximately 200-300 μs. The stimulation intensity is adjusted individually to produce a light tingling sensation without discomfort or visible muscle contraction.
Study Details
The purpose of this study is to measure the change in dizziness, as measured by change in Dizziness Handicap Inventory (DHI) score, following a 4-week treatment period with auricular transcutaneous vagus nerve stimulation (aTVNS).
Key Dates
- Start date
- Mar 23, 2026
- Status verified
- Feb 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Auricular transcutaneous vagus nerve stimulationThe vagus nerve stimulation group will perform two sessions per day (morning and evening), each lasting approximately 30 minutes, for a total of 1 hour of auricular transcutaneous vagus nerve stimulation. This arm will continue using the active treatment for 8 weeks.
- Sham Comparator: Sound sham electrodesThe sham control group will will perform two sessions per day (morning and evening), each lasting approximately 30 minutes, for a total of 1 hour of daily stimulation using the sham device. After 4 weeks, the sham control group will begin active auricular transcutaneous vagus nerve stimulation for 4 weeks.
Primary Outcome Measure
Change in Dizziness Handicap Inventory (DHI) score [ Time Frame: Baseline, 4 weeks ]
Central Contacts
- Colton Clayton, Au.D., Ph.D.904-953-2945
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | Colton Clayton, Au.D., Ph.D. Colton Clayton, Au.D., Ph.D. (PRINCIPAL_INVESTIGATOR) |
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