Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:11 AM
Study NCT ID:
NCT07420803
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Dizziness Handicap Inventory (DHI) score', 'timeFrame': 'Baseline, 4 weeks', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in Anxiety (HADS-A)', 'timeFrame': 'Baseline, 4 weeks and 8 weeks', 'description': '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.'}, {'measure': 'Change in Postural Sway', 'timeFrame': 'Baseline, 4 weeks and 8 weeks', 'description': 'Postural sway will be measured using Computerized Dynamic Posturography. A ≥10-15% reduction will be considered a meaningful improvement.'}, {'measure': 'Weekly averages of dizzy-day frequency', 'timeFrame': 'Through end of study, approximately 8 weeks', 'description': 'Frequency of dizzy days will be tracked via patient treatment diary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vagus Nerve Stimulation'], 'conditions': ['Chronic Dizziness', 'Persistent Postural Perceptual Dizziness']}, 'referencesModule': {'references': [{'pmid': '32410932', 'type': 'BACKGROUND', 'citation': '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': '27898202', 'type': 'BACKGROUND', 'citation': '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': '36941047', 'type': 'BACKGROUND', 'citation': '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': '17309987', 'type': 'BACKGROUND', 'citation': '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': '29036855', 'type': 'BACKGROUND', 'citation': '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': '30315375', 'type': 'BACKGROUND', 'citation': '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': '29208729', 'type': 'BACKGROUND', 'citation': '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': '30607985', 'type': 'BACKGROUND', 'citation': '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': '25573069', 'type': 'BACKGROUND', 'citation': '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': '29785522', 'type': 'BACKGROUND', 'citation': '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': '22104568', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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 aurical transcutaneous vagus nerve stimulation (aTVNS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75, PPPD diagnosis per ICVD.\n* Persistent dizziness ≥3 months and at least 1 dizziness exacerbation/day during 2-week run-in.\n* On stable medications/therapy for ≥4 weeks prior to baseline (if any).\n\nExclusion Criteria:\n\n* Uncompensated peripheral/central vestibular deficit, sensory-afferent or cerebellar ataxia.\n* Cardiac disease (coronary disease, unstable arrhythmia), recurrent syncope (\\>1 in past 12 months).\n* Neck surgery, vagotomy, or any condition interfering with vagal stimulation.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT07420803', 'briefTitle': 'A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Efficacy Of Auricular Transcutaneous Vagus Nerve Stimulation In Treating Chronic Dizziness', 'orgStudyIdInfo': {'id': '25-012683'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auricular transcutaneous vagus nerve stimulation', 'description': '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.', 'interventionNames': ['Other: Auricular transcutaneous vagus nerve stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sound sham electrodes', 'description': '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.', 'interventionNames': ['Other: Sham Device', 'Other: Auricular transcutaneous vagus nerve stimulation']}], 'interventions': [{'name': 'Sham Device', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Sound sham electrodes']}, {'name': 'Auricular transcutaneous vagus nerve stimulation', 'type': 'OTHER', 'description': '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.\n\nThe stimulator produces mild, pulsed electrical currents typically ranging from 0.1 to 5.0 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.', 'armGroupLabels': ['Auricular transcutaneous vagus nerve stimulation', 'Sound sham electrodes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colton Clayton, Au.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'Colton Clayton, Au.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Colton Clayton, Au.D., Ph.D.', 'role': 'CONTACT', 'email': 'clayton.colton@mayo.edu', 'phone': '904-953-2945'}], 'overallOfficials': [{'name': 'Colton Clayton, Au.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Colton T. Clayton', 'investigatorAffiliation': 'Mayo Clinic'}}}}