Recruiting NCT07420803
A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sham Device, Auricular transcutaneous vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Chronic Dizziness, Persistent Postural Perceptual Dizziness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy Of Auricular Transcutaneous Vagus Nerve Stimulation In Treating Chronic Dizziness
Overview
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).
Interventions
- Other Sham Device
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. - Other Auricular transcutaneous vagus nerve stimulation
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 wit
Primary outcome measures
- Change in Dizziness Handicap Inventory (DHI) score [Time frame: Baseline, 4 weeks]
Secondary outcome measures (3)
- Change in Anxiety (HADS-A) [Time frame: Baseline, 4 weeks and 8 weeks]
- Change in Postural Sway [Time frame: Baseline, 4 weeks and 8 weeks]
- Weekly averages of dizzy-day frequency [Time frame: Through end of study, approximately 8 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
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. PMID 32410932
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07420803 · 25-012683