Ear-based vagus nerve stimulation for persistent dizziness
Efficacy Of Auricular Transcutaneous Vagus Nerve Stimulation In Treating Chronic Dizziness
Researchers will try ear-based (auricular) transcutaneous vagus nerve stimulation for adults with persistent postural-perceptual dizziness to see if it reduces dizziness over a four-week treatment period.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07420803 on ClinicalTrials.gov |
What this trial studies
Adults with a formal diagnosis of persistent postural-perceptual dizziness (PPPD) will be assigned to receive either active auricular transcutaneous vagus nerve stimulation or a sham device over a four-week treatment period. The primary outcome is change in dizziness measured by the Dizziness Handicap Inventory (DHI) from baseline to the end of treatment. Eligible participants must have had dizziness for at least three months and at least one daily dizziness exacerbation during a two-week run-in, and must be on stable therapies for four weeks prior to baseline. The trial is conducted at the Mayo Clinic in Florida and collects symptom and safety data throughout the treatment period.
Who should consider this trial
Good fit: Adults aged 18–75 with a PPPD diagnosis per the International Classification of Vestibular Disorders, persistent dizziness for ≥3 months, and at least one daily exacerbation during a two-week run-in are the intended participants.
Not a fit: Patients with uncompensated peripheral or central vestibular deficits, sensory-afferent or cerebellar ataxia, significant cardiac disease or recurrent syncope, prior neck surgery or vagotomy, pregnancy, or other conditions that interfere with vagal stimulation are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, this noninvasive ear-based stimulation could reduce dizziness and improve daily function for people with PPPD.
How similar studies have performed: Noninvasive vagus nerve stimulation has shown promise in other neurological and pain conditions, but its use specifically for chronic dizziness or PPPD is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75, Persistent Postural-Perceptual Dizziness (PPPD) diagnosis per International Classification of Vestibular Disorders (ICVD). * Persistent dizziness ≥3 months and at least 1 dizziness exacerbation/day during 2-week run-in. * On stable medications/therapy for ≥4 weeks prior to baseline (if any). Exclusion Criteria: * Uncompensated peripheral/central vestibular deficit, sensory-afferent or cerebellar ataxia. * Cardiac disease (coronary disease, unstable arrhythmia), recurrent syncope (\>1 in past 12 months). * Neck surgery, vagotomy, or any condition interfering with vagal stimulation. * Pregnancy.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Colton Clayton, Au.D., Ph.D. — Mayo Clinic
- Study coordinator: Colton Clayton, Au.D., Ph.D.
- Email: clayton.colton@mayo.edu
- Phone: 904-953-2945
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.