UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063445 |
|---|---|
| Receipt number | R000072618 |
| Scientific Title | Effects of transcutaneous auricular vagus nerve stimulation (taVNS) on A delta- and C-fiber-related nociceptive responses: A single-blind, randomized, crossover, controlled trial |
| Date of disclosure of the study information | 2026/10/29 |
| Last modified on | 2026/10/28 16:09:40 |
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Basic information
Public title
Effects of transcutaneous auricular vagus nerve stimulation (taVNS) on nociceptive neurotransmission
Acronym
TAVNS-PAIN
Scientific Title
Effects of transcutaneous auricular vagus nerve stimulation (taVNS) on A delta- and C-fiber-related nociceptive responses: A single-blind, randomized, crossover, controlled trial
Scientific Title:Acronym
TAVNS-AC-NOCI
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While conventional vagus nerve stimulation (VNS) required surgical implantation, non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) has overcome this drawback, with reported efficacy in treating epilepsy and chronic pain. However, its analgesic effects on acute pain and the underlying detailed mechanisms remain largely elusive. Furthermore, conventional pain assessments have faced limitations due to their heavy reliance on subjective measures such as the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS). To address these gaps, this study aims to scientifically elucidate the direct modulatory effects of taVNS on A delta- and C-fiber-mediated nociceptive transmission, as well as its activating effects on the descending pain inhibitory system, by utilizing time-space-frequency analysis of multichannel electroencephalography (EEG). Ultimately, this research seeks to establish a robust scientific foundation that contributes to future personalized medicine and the optimization of postoperative pain management. As an indispensable preliminary step toward clinical application, this study first comprehensively investigates the effects of taVNS on nociceptive information processing pathways in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalographic changes induced by intraepidermal electrical stimulation (IES) 30 minutes after the cessation of stimulation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Each participant will undergo two types of interventions-taVNS followed by sham stimulation-with an interval of at least 7 days between sessions. All participants will receive the taVNS intervention first, followed by the sham intervention. For the taVNS intervention, stimulation will be applied to the left cymba conchae at a frequency of 30 Hz for 60 minutes. The intensity will be adjusted to a level where the participant perceives a tingling sensation but experiences no pain or discomfort. For the sham intervention, the device will be attached to the same site (the left cymba conchae) for 60 minutes, but no electrical stimulation will be delivered.
Interventions/Control_2
Each participant will undergo two types of interventions-sham followed by taVNS stimulation-with an interval of at least 7 days between sessions. All participants will receive the sham intervention first, followed by the taVNS intervention. For the sham intervention, the device will be attached to the left cymba conchae for 60 minutes, but no electrical stimulation will be delivered. For the taVNS intervention, stimulation will be applied to the same site (the left cymba conchae) at a frequency of 30 Hz for 60 minutes. The intensity will be adjusted to a level where the participant perceives a tingling sensation but experiences no pain or discomfort.
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. Individuals who understand the purpose of this study and provide written informed consent to participate.
2. Individuals aged 18 years or older at the time of providing consent.
Key exclusion criteria
1. Individuals with a history or complication of central nervous system, neuromuscular, or cardiovascular diseases.
2. Women who are pregnant, possibly pregnant, lactating, or planning to become pregnant.
3. Individuals with skin diseases at the site of surface stimulation electrode placement.
4. Individuals with implanted metallic devices (e.g., cardiac pacemakers, cochlear implants).
5. Individuals who regularly use analgesics.
6. Any other individuals deemed unsuitable for participation by the principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kido |
Organization
Hiroshima University Hospital
Division name
Department of Anesthesiology
Zip code
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5267
masuika@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kido |
Organization
Hiroshima University Hospital
Division name
Department of Anesthesiology
Zip code
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5267
Homepage URL
masuika@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 12 | 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 | 28 | Day |
Last modified on
| 2026 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072618
