UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062440 |
|---|---|
| Receipt number | R000071342 |
| Scientific Title | Exploratory Clinical Trial of vagal nerve stimulation for Dizziness |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/02 16:30:32 |
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Basic information
Public title
Exploratory Clinical Trial of vagal nerve stimulation for Dizziness
Acronym
Exploratory Clinical Trial of vagal nerve stimulation for Dizziness
Scientific Title
Exploratory Clinical Trial of vagal nerve stimulation for Dizziness
Scientific Title:Acronym
Exploratory Clinical Trial of vagal nerve stimulation for Dizziness
Region
| Japan |
Condition
Condition
peripheral vestibular disorders
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in symptoms evaluated by comparing Dizziness Handicap Inventory (DHI) and Vertigo Symptom Scale (VSS) scores at baseline and 20 weeks after initiating low-frequency vagal nerve stimulation
Key secondary outcomes
1. Safety and the incidence of adverse events associated with vagal nerve stimulation
2. Changes in quality of life (QoL) before and after vagal nerve stimulation, assessed by the Visual Analogue Scale (VAS) and EuroQol 5-Dimension questionnaire (EQ-5D)
3. Occurrence of vertigo attacks during vagal nerve stimulation
4. Immune cell localization before and after vagal nerve stimulation, positivity and intensity of inflammation-induced molecular expression, presence or absence of disease-associated gene variants, and their association with pathophysiology, as well as correlations between inflammatory status and expression profiles of other analyzed molecules
5. Correlation between MRI-derived brain activity data and the expression profiles of various analyzed molecules
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Homma |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Otolaryngology-Head & Neck Surgery
Zip code
0608638
Address
Kita-Ku, N15W7, Sapporo
TEL
011-706-5958
ak-homma@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Fujiwara |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Otolaryngology-Head & Neck Surgery
Zip code
0608638
Address
Kita-Ku, N15W7, Sapporo
TEL
011-706-5958
Homepage URL
boron700@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research Administration Center
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
011-716-1161
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 02 | Day |
Last modified on
| 2026 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071342
