UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060628 |
|---|---|
| Receipt number | R000069344 |
| Scientific Title | Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI |
| Date of disclosure of the study information | 2026/02/09 |
| Last modified on | 2026/02/09 16:38:27 |
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Basic information
Public title
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI
Acronym
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI
Scientific Title
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI
Scientific Title:Acronym
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of taVNS intervention with a modified stimulation frequency of 100Hz on the neural excitation suppression function (SEP, PPI) in athletes with chronic pain and healthy athletes. By examining the impact of different stimulation conditions on central nervous system suppression mechanisms, we aim to obtain fundamental insights for developing more effective taVNS stimulation conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The experiment involves administering transcutaneous auricular vagus nerve stimulation to participants, measuring SEP and PPI before and after stimulation, and investigating the effects on inhibitory responses.
Since vagus nerve stimulation is suggested to promote parasympathetic dominance and potentially reduce pain, it can clarify the effects on neural inhibitory function in chronic pain patients.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcutaneous Vagus Nerve Stimulation,Elctroencephalogram
Interventions/Control_2
sham Stimulation
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
| 24 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy adult
Pain that has persisted for more than three months
Key exclusion criteria
Skin disorders, neurological disorders,
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | yumeki |
| Middle name | |
| Last name | hara |
Organization
Niigata University of Health and Welfare
Division name
Field of Health and sports
Zip code
950-3198
Address
Niigata 950-3198,Japan
TEL
080-8145-9138
wtm25003@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Koya |
| Middle name | |
| Last name | Yamashiro |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
Niigata 950-3198,Japan
TEL
025-257-4757
Homepage URL
yamashiro@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Niigata 950-3198,Japan
Tel
025-257-4500
wtm25003@nuhw.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 | 02 | Month | 09 | 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 | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 01 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069344
