Chronic DizzinessNCT07420803
A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness
A study testing Auricular transcutaneous vagus nerve stimulation in people with Chronic Dizziness and Persistent Postural Perceptual Dizziness, run by Mayo Clinic at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Dizziness, Persistent Postural Perceptual Dizziness
- What is being tested?
- Auricular transcutaneous vagus nerve stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy Of Auricular Transcutaneous Vagus Nerve Stimulation In Treating Chronic Dizziness
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).
- Being tested
- Sham Device, Auricular transcutaneous vagus nerve stimulation
- Keywords
- Vagus Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham DeviceOther
The 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 stimulationOther
The 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 group | Role | What they receive |
|---|---|---|
| Auricular transcutaneous vagus nerve stimulation | Experimental | The 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. Receives: Other: Auricular transcutaneous vagus nerve stimulation |
| Sound sham electrodes | Sham comparator | The 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. Receives: Other: Sham Device; Other: Auricular transcutaneous vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dizziness Handicap Inventory (DHI) score
The Dizziness Handicap Inventory (DHI) is a 25-item questionnaire assesses physical, emotional, and functional aspects of dizziness. Each of the 25 questions has three answers: "Always" (4 points), "Sometimes" (2 points), or "No" (0 points). Scores are summed for a total from 0 (no disability) to 100 (maximum disability).
Measured: Baseline, 4 weeks
Secondary outcomes (3)
Change in Anxiety (HADS-A)
The Hospital Anxiety and Depression (HAD) is a self-reported 14 item questionnaire asking participants to reflect on their mood in the past week. . Each item is rated on a 4-point scale, for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress. Clinically meaningful change is defined as a ≥2-3-point reduction.
Measured: Baseline, 4 weeks and 8 weeks
Change in Postural Sway
Postural sway will be measured using Computerized Dynamic Posturography. A ≥10-15% reduction will be considered a meaningful improvement.
Measured: Baseline, 4 weeks and 8 weeks
Weekly averages of dizzy-day frequency
Frequency of dizzy days will be tracked via patient treatment diary
Measured: Through end of study, approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start23 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic DizzinessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colton T. Clayton, Mayo Clinic
- Investigators
- Colton Clayton, Au.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420803
- Sponsor's protocol ID
- 25-012683
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yap JYY, Keatch C, Lambert E, Woods W, Stoddart PR, Kameneva T. Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice. Front Neurosci. 2020 Apr 28;14:284. doi: 10.3389/fnins.2020.00284. eCollection 2020.
PubMed 32410932Yakunina N, Kim SS, Nam EC. Optimization of Transcutaneous Vagus Nerve Stimulation Using Functional MRI. Neuromodulation. 2017 Apr;20(3):290-300. doi: 10.1111/ner.12541. Epub 2016 Nov 29.
PubMed 27898202Trinidade A, Cabreira V, Goebel JA, Staab JP, Kaski D, Stone J. Predictors of persistent postural-perceptual dizziness (PPPD) and similar forms of chronic dizziness precipitated by peripheral vestibular disorders: a systematic review. J Neurol Neurosurg Psychiatry. 2023 Nov;94(11):904-915. doi: 10.1136/jnnp-2022-330196. Epub 2023 Mar 20.
PubMed 36941047Staab JP, Ruckenstein MJ. Expanding the differential diagnosis of chronic dizziness. Arch Otolaryngol Head Neck Surg. 2007 Feb;133(2):170-6. doi: 10.1001/archotol.133.2.170.
PubMed 17309987Staab JP, Eckhardt-Henn A, Horii A, Jacob R, Strupp M, Brandt T, Bronstein A. Diagnostic criteria for persistent postural-perceptual dizziness (PPPD): Consensus document of the committee for the Classification of Vestibular Disorders of the Barany Society. J Vestib Res. 2017;27(4):191-208. doi: 10.3233/VES-170622.
PubMed 29036855Popkirov S, Stone J, Holle-Lee D. Treatment of Persistent Postural-Perceptual Dizziness (PPPD) and Related Disorders. Curr Treat Options Neurol. 2018 Oct 13;20(12):50. doi: 10.1007/s11940-018-0535-0.
PubMed 30315375Popkirov S, Staab JP, Stone J. Persistent postural-perceptual dizziness (PPPD): a common, characteristic and treatable cause of chronic dizziness. Pract Neurol. 2018 Feb;18(1):5-13. doi: 10.1136/practneurol-2017-001809. Epub 2017 Dec 5.
PubMed 29208729Nada EH, Ibraheem OA, Hassaan MR. Vestibular Rehabilitation Therapy Outcomes in Patients With Persistent Postural-Perceptual Dizziness. Ann Otol Rhinol Laryngol. 2019 Apr;128(4):323-329. doi: 10.1177/0003489418823017. Epub 2019 Jan 4.
PubMed 30607985Frangos E, Ellrich J, Komisaruk BR. Non-invasive Access to the Vagus Nerve Central Projections via Electrical Stimulation of the External Ear: fMRI Evidence in Humans. Brain Stimul. 2015 May-Jun;8(3):624-36. doi: 10.1016/j.brs.2014.11.018. Epub 2014 Dec 6.
PubMed 25573069Eren OE, Filippopulos F, Sonmez K, Mohwald K, Straube A, Schoberl F. Non-invasive vagus nerve stimulation significantly improves quality of life in patients with persistent postural-perceptual dizziness. J Neurol. 2018 Oct;265(Suppl 1):63-69. doi: 10.1007/s00415-018-8894-8. Epub 2018 May 21.
PubMed 29785522Edelman S, Mahoney AE, Cremer PD. Cognitive behavior therapy for chronic subjective dizziness: a randomized, controlled trial. Am J Otolaryngol. 2012 Jul-Aug;33(4):395-401. doi: 10.1016/j.amjoto.2011.10.009. Epub 2011 Nov 21.
PubMed 22104568