Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice.
Jonathan Y Y Yap, Charlotte Keatch, Elisabeth Lambert...
https://pubmed.ncbi.nlm.nih.gov/32410932Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07420803
Efficacy Of Auricular Transcutaneous Vagus Nerve Stimulation In Treating Chronic Dizziness
Led by Mayo Clinic · Updated on 2026-04-17
60
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating auricular transcutaneous vagus nerve stimulation (aTVNS) as a treatment for chronic dizziness, including Persistent Postural-Perceptual Dizziness (PPPD). The study aims to measure changes in dizziness using the Dizziness Handicap Inventory (DHI) score after a 4-week treatment period. This is a randomized, double-blind trial sponsored by Mayo Clinic that compares active aTVNS with a sham control device. Participants are randomly assigned to one of two groups. The active treatment group will perform two daily sessions of aTVNS, each about 30 minutes, totaling 1 hour per day for 8 weeks. The sham control group will perform two daily sessions using a device that mimics stimulation without electrical current for 4 weeks, then switch to the active treatment for the remaining 4 weeks. The aTVNS device delivers mild electrical pulses to the ear to stimulate the vagus nerve. During the study, participants will complete assessments at baseline, 4 weeks, and 8 weeks. Researchers will measure dizziness changes using the DHI score, anxiety levels, postural sway, and frequency of dizzy days. The study includes monitoring of symptoms and safety throughout the approximately 8-week period. The goal is to understand the effects of aTVNS on dizziness and related symptoms in adults with PPPD.
CONDITIONS
Brief Title
A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18-75 years
- Diagnosis of Persistent Postural-Perceptual Dizziness (PPPD) according to International Classification of Vestibular Disorders
- Persistent dizziness for 3 months or more
- At least one dizziness worsening episode per day during a 2-week run-in period
- Stable medications or therapy for 4 weeks prior to baseline (if any)
You will not qualify if you...
- Uncompensated peripheral or central vestibular deficit, sensory-afferent or cerebellar ataxia
- Cardiac disease such as coronary disease or unstable arrhythmia
- History of recurrent fainting episodes (more than once in the past 12 months)
- Neck surgery, vagotomy, or any condition interfering with vagal nerve stimulation
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 8 weeks
Participants receive auricular transcutaneous vagus nerve stimulation or sham stimulation twice daily for 8 weeks to treat chronic dizziness.
Twice daily sessions, each lasting approximately 30 minutes, for a total of 1 hour daily
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
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Research Team
C
Colton Clayton, Au.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Optimization of Transcutaneous Vagus Nerve Stimulation Using Functional MRI.
Natalia Yakunina, Sam Soo Kim, Eui-Cheol Nam
https://pubmed.ncbi.nlm.nih.gov/27898202Predictors of persistent postural-perceptual dizziness (PPPD) and similar forms of chronic dizziness precipitated by peripheral vestibular disorders: a systematic review.
Aaron Trinidade, Verónica Cabreira, Joel A Goebel...
https://pubmed.ncbi.nlm.nih.gov/36941047Expanding the differential diagnosis of chronic dizziness.
Jeffrey P Staab, Michael J Ruckenstein
https://pubmed.ncbi.nlm.nih.gov/17309987Diagnostic criteria for persistent postural-perceptual dizziness (PPPD): Consensus document of the committee for the Classification of Vestibular Disorders of the Bárány Society.
Jeffrey P Staab, Annegret Eckhardt-Henn, Arata Horii...
https://pubmed.ncbi.nlm.nih.gov/29036855Treatment of Persistent Postural-Perceptual Dizziness (PPPD) and Related Disorders.
Stoyan Popkirov, Jon Stone, Dagny Holle-Lee
https://pubmed.ncbi.nlm.nih.gov/30315375Persistent postural-perceptual dizziness (PPPD): a common, characteristic and treatable cause of chronic dizziness.
Stoyan Popkirov, Jeffrey P Staab, Jon Stone
https://pubmed.ncbi.nlm.nih.gov/29208729Vestibular Rehabilitation Therapy Outcomes in Patients With Persistent Postural-Perceptual Dizziness.
Ebtessam H Nada, Ola A Ibraheem, Mohammad R Hassaan
https://pubmed.ncbi.nlm.nih.gov/30607985Non-invasive Access to the Vagus Nerve Central Projections via Electrical Stimulation of the External Ear: fMRI Evidence in Humans.
Eleni Frangos, Jens Ellrich, Barry R Komisaruk
https://pubmed.ncbi.nlm.nih.gov/25573069Non-invasive vagus nerve stimulation significantly improves quality of life in patients with persistent postural-perceptual dizziness.
Ozan E Eren, Filipp Filippopulos, Kristina Sönmez...
https://pubmed.ncbi.nlm.nih.gov/29785522