A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness

NCT07420803 | Recruiting

• 1 other identifier: 25-012683
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Persistent Postural Perceptual Dizziness; Chronic Dizziness

Keywords

Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 4 weeks

Secondary Outcomes (3)

• Change in Anxiety (HADS-A)

  Baseline, 4 weeks and 8 weeks

• Change in Postural Sway

  Baseline, 4 weeks and 8 weeks

• Weekly averages of dizzy-day frequency

  Through end of study, approximately 8 weeks

Study Arms (2)

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.

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.

Other: Sham Device; Other: Auricular transcutaneous vagus nerve stimulation

Interventions

Auricular transcutaneous vagus nerve stimulation OTHER

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.

Auricular transcutaneous vagus nerve stimulation; Sound sham electrodes

Sham Device OTHER

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.

Sound sham electrodes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 32410932 BACKGROUND

• Yakunina 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.

  PMID: 27898202 BACKGROUND

• Trinidade 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.

  PMID: 36941047 BACKGROUND

• Staab 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.

  PMID: 17309987 BACKGROUND

• Staab 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.

  PMID: 29036855 BACKGROUND

• Popkirov 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.

  PMID: 30315375 BACKGROUND

• Popkirov 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.

  PMID: 29208729 BACKGROUND

• Nada 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.

  PMID: 30607985 BACKGROUND

• Frangos 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.

  PMID: 25573069 BACKGROUND

• Eren 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.

  PMID: 29785522 BACKGROUND

• Edelman 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.

  PMID: 22104568 BACKGROUND

Study Officials

• Colton Clayton, Au.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colton Clayton, Au.D., Ph.D.

CONTACT

904-953-2945; clayton.colton@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)