Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062440) titled 'Exploratory Clinical Trial of vagal nerve stimulation for Dizziness' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Hokkaido University

Condition: Condition - peripheral vestibular disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the efficacy, safety, and incidence of adverse events of vagal nerve stimulation targeting the auricular branch of the vagal nerve in patients with peripheral vestibular disorders who remain symptomatic or experience recurrent attacks despite standard medical therapy, as well as its impact on inflammatory control, including immune system responses. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - During a run-in period of up to 8 weeks, baseline evaluations including disease activity will be performed. Following the initiation of vagal nerve stimulation, various clinical parameters will be evaluated at Week 4 and every 8 weeks thereafter over a 20-week intervention period. Auricular stimulation using a Class II controlled medical device will be administered once daily for 1 hour for 20 weeks.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Aged 18 years or older at the time of obtaining informed consent. 2. Clinically diagnosed with peripheral vestibular disorders that is refractory to medical therapy. 3. Presenting with symptoms such as nystagmus or unsteadiness. 4. Capable of fully understanding the study details and providing voluntary written informed consent after receiving a thorough explanation. Key exclusion criteria - 1. History of acute heart failure, myocardial infarction, pulmonary edema, or acute exacerbation of interstitial pneumonia within the past 3 months. 2. History of progressive brain lesions. 3. Vertigo symptoms caused by acoustic neuroma. 4. Concurrent use of vagal nerve stimulation therapy. 5. History of epilepsy. 6. History of severe cardiovascular disease. 7. Presence of pneumothorax. 8. Uncontrolled infection. 9. History of hypersensitivity to glycerin. 10. Pregnant or lactating women. 11. Skin hypersensitivity or a history of skin reactions triggered by metals or other substances. 12. Difficulty with oral intake. 13. Severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min). 14. Use of a cardiac pacemaker or implantable cardioverter-defibrillator (ICD). 15. Any other condition deemed unsuitable for study participation by the principal investigator or co-investigators. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 07 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071342

Disclaimer: Curated by HT Syndication.