UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063327 |
|---|---|
| Receipt number | R000071745 |
| Scientific Title | Investigation of Anatomical Factors Determining Responsiveness to Transcutaneous Auricular Vagus Nerve Stimulation and Development of Individualized Stimulation Methods |
| Date of disclosure of the study information | 2026/10/31 |
| Last modified on | 2026/10/18 01:22:50 |
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Basic information
Public title
Study of Ear Anatomical Features Related to the Response to Vagus Nerve Stimulation of the Ear
Acronym
Study of Ear Anatomy and Response to Vagus Nerve Stimulation
Scientific Title
Investigation of Anatomical Factors Determining Responsiveness to Transcutaneous Auricular Vagus Nerve Stimulation and Development of Individualized Stimulation Methods
Scientific Title:Acronym
Anatomical Factors in taVNS
Region
| Japan |
Condition
Condition
ear disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using temporal bone CT images, we will evaluate anatomical features related to the course of the auricular branch of the vagus nerve (Arnold's nerve), including the tympanomastoid fissure and external auditory canal morphology, and analyze their associations with changes in pupil diameter induced by transcutaneous auricular vagus nerve stimulation (taVNS) as the primary outcome. Furthermore, we will investigate the associations of these anatomical features with the sensory and pain thresholds for taVNS, the presence or absence of the Arnold reflex (cough reflex), and changes in subjective symptoms such as tinnitus, dizziness, and aural fullness. Through these analyses, we aim to identify anatomical factors that determine responsiveness to taVNS and establish imaging-based markers that may contribute to the development of individualized neuromodulation therapy.
Basic objectives2
Others
Basic objectives -Others
To explore the associations between physiological responses and stimulation thresholds to transcutaneous auricular vagus nerve stimulation (taVNS) and anatomical features, and to identify imaging-based markers that may contribute to the development of individualized stimulation methods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in pupil diameter before and after transcutaneous auricular vagus nerve stimulation (taVNS)
Key secondary outcomes
1.Sensory and pain thresholds for transcutaneous auricular vagus nerve stimulation (taVNS)
2.Presence or absence of the Arnold reflex (cough reflex) induced by taVNS
3.Changes in subjective symptoms, including tinnitus, dizziness, and aural fullness, before and after taVNS
4.Associations between anatomical features related to the course of Arnold's nerve, including the tympanomastoid fissure and external auditory canal morphology, assessed using temporal bone CT, and changes in pupil diameter induced by taVNS
5.Associations between anatomical features and sensory and pain thresholds for taVNS and the presence or absence of the Arnold reflex
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to the left auricle, targeting the tragus or cymba conchae. Constant-current stimulation will be delivered at a frequency of 20-25 Hz with a pulse width of 200-500 us. The stimulation intensity will be set below the participant's pain threshold and at a comfortable level without discomfort. Stimulation will be performed for 5-30 minutes, and pupil diameter will be measured before and after stimulation. Stimulation intensity, sensory and pain thresholds, the Arnold reflex (cough reflex), and changes in subjective symptoms will also be assessed.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 to 70 years
Individuals who have received sufficient explanation of the study and have provided written informed consent
Individuals with available temporal bone CT images
Healthy individuals or patients with tinnitus, dizziness, or aural fullness
Key exclusion criteria
Individuals with a cardiac pacemaker or implantable cardioverter-defibrillator
Individuals who are pregnant or may be pregnant
Individuals with active ear disease in the left ear, such as otitis externa or otitis media
Individuals with wounds or skin disorders of the left auricle
Individuals with a history of epilepsy
Individuals with severe cardiovascular disease
Individuals with severe psychiatric disorders
Individuals currently taking medications that significantly affect autonomic nervous system function
Individuals deemed unsuitable for participation by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Nagase |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
501-1193
Address
1-1, Yanagido, Gifu City, Gifu, 501-1193, Japan
TEL
058-230-6000
nagase.noriko.n3@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Nagase |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
501-1193
Address
1-1, Yanagido, Gifu City, Gifu, 501-1193, Japan
TEL
058-230-6000
Homepage URL
nagase.noriko.n3@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Gifu University Graduate School of Medicine
Address
1-1, Yanagido, Gifu City, Gifu, 501-1193, Japan
Tel
058-230-6059
rinri@t.gifu-u.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
岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 31 | 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 | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | 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 | 10 | Month | 18 | Day |
Last modified on
| 2026 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071745
