UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057997 |
|---|---|
| Receipt number | R000065702 |
| Scientific Title | The Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI |
| Date of disclosure of the study information | 2025/05/28 |
| Last modified on | 2025/05/28 13:01:31 |
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Basic information
Public title
The Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI
Acronym
The Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI
Scientific Title
The Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI
Scientific Title:Acronym
The Effects of Transcutaneous Auricular Vagus Nerve Stimulation on SEP and PPI
Region
| Japan |
Condition
Condition
Chronic pain syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that athletes with chronic pain have reduced neural inhibition function in the somatosensory area compared to healthy athletes. As a method to improve this phenomenon, transcutaneous auricular vagus nerve stimulation (taVNS) is considered the most effective. The rationale behind this is that taVNS is non-invasive, safe, and has minimal and temporary side effects, making it widely used in recent studies. Furthermore, previous research has suggested that vagus nerve stimulation activates the parasympathetic nervous system, which may lead to pain relief. However, the relationship between taVNS and neural inhibition function remains unclear. Therefore, this study aims to clarify the effects of taVNS on neural inhibition function in athletes with chronic pain and healthy athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The study will include 20 healthy athletes and 20 athletes with chronic pain as participants.
In the experiment, participants will undergo transcutaneous auricular vagus nerve stimulation (taVNS), and somatosensory evoked potentials (SEP) and prepulse inhibition (PPI) will be measured before and after stimulation to examine the effects on inhibitory responses.
Electrocardiography (ECG) and electroencephalography (EEG) will also be recorded to assess changes in heart rate, autonomic nervous system activity, and the effects on the brain.
By administering taVNS to both athletes with chronic pain and healthy athletes and evaluating neural inhibition function before and after stimulation, this study aims to provide evidence regarding the effectiveness and potential of taVNS.
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
Administer a single 15-minute session of transcutaneous auricular vagus nerve stimulation (taVNS).
Interventions/Control_2
sham
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
| 20 | years-old | <= |
Age-upper limit
| 23 | years-old | > |
Gender
Male
Key inclusion criteria
Twenty healthy athletes and twenty athletes with chronic pain lasting more than three months from the Track and Field Club of Niigata University of Health and Welfare.
Key exclusion criteria
Athletes with skin disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hikari |
| Middle name | |
| Last name | Ogawa |
Organization
Niigata University of Health and Welfare
Division name
Division of Health and Sports Sciences, Department of Health Sciences
Zip code
950-3111
Address
Room 202, Bright Town, 1-29-28 Tayuhama-Shinmachi, Kita-ku, Niigata-shi, Niigata, 950-3112, Japan
TEL
080-9561-6762
wtm24007@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kouya |
| Middle name | |
| Last name | Yamashiro |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports Sciences
Zip code
950-3198
Address
1398 Shimami-machi, Kita-ku, Niigata-shi, 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
Other
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
Ethics Review Committee of Niigata University of Health and Welfare
Address
1398 Shimami-machi, Kita-ku, Niigata-shi, Niigata, 950-3198, Japan
Tel
025-257-4757
rinri@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
| 2025 | Year | 05 | Month | 28 | 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
| 2025 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065702
