UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063448 |
|---|---|
| Receipt number | R000072623 |
| Scientific Title | Effects of transcutaneous auricular vagus nerve stimulation (taVNS) on the reward system and motor performance: investigation of the underlying mechanisms |
| Date of disclosure of the study information | 2026/10/29 |
| Last modified on | 2026/10/28 20:28:59 |
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Basic information
Public title
Effects of electrical stimulation of the ear on brain responses to reward and motor learning
Acronym
Ear Stimulation, Reward, and Motor Learning Study
Scientific Title
Effects of transcutaneous auricular vagus nerve stimulation (taVNS) on the reward system and motor performance: investigation of the underlying mechanisms
Scientific Title:Acronym
taVNS, Reward System, and Motor Performance Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on reward-related neural activity and motor performance during a motor learning task in healthy adults, and to explore the underlying neurophysiological mechanisms.
Basic objectives2
Others
Basic objectives -Others
Investigation of the neurophysiological and behavioral effects of transcutaneous auricular vagus nerve stimulation in healthy adults.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Task 1: Pre-to-post intervention change in reward positivity (RewP) during the reward task.
Task 2: Motor performance in the tracking task before and after the intervention.
Key secondary outcomes
Tasks 1 and 2: Heart rate variability (HRV) before, during, and after the intervention; subjective motivation and fatigue before and after the intervention; and mood state assessed using the short form of the Profile of Mood States 2 (POMS 2) at baseline.
Task 2: Brain activity assessed using electroencephalography during the motor learning task.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Task 1: Active taVNS group
A single 20-minute session of transcutaneous auricular vagus nerve stimulation is applied to the left cymba conchae.
Interventions/Control_2
Task 1: Sham taVNS group
A single 20-minute sham stimulation session is conducted with electrodes placed on the left cymba conchae. Electrical stimulation is delivered only during the first 30 seconds.
Interventions/Control_3
Task 2: Active taVNS plus feedback group
A single 20-minute session of transcutaneous auricular vagus nerve stimulation is applied to the left cymba conchae. Verbal feedback on tracking task performance is provided during stimulation.
Interventions/Control_4
Task 2: Active taVNS group
A single 20-minute session of transcutaneous auricular vagus nerve stimulation is applied to the left cymba conchae. No verbal feedback on tracking task performance is provided.
Interventions/Control_5
Task 2: Sham taVNS plus feedback group
A single 20-minute sham stimulation session is conducted with electrodes placed on the left cymba conchae. Electrical stimulation is delivered only during the first 30 seconds. Verbal feedback on tracking task performance is provided during the session.
Interventions/Control_6
Task 2: Sham taVNS group
A single 20-minute sham stimulation session is conducted with electrodes placed on the left cymba conchae. Electrical stimulation is delivered only during the first 30 seconds. No verbal feedback on tracking task performance is provided.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults aged 18-40 years with no history of or current diagnosis of neurological, psychiatric, or cardiac disease.
2. Individuals with no current orthopedic condition or residual effects of an orthopedic condition that would interfere with the button-clicking or pinching movements required for this study.
3. Individuals who provide written informed consent after receiving a sufficient explanation of the study.
Key exclusion criteria
1.Individuals with metal or implanted devices, such as cochlear implants, pacemakers, deep brain stimulators, or drug infusion pumps, near the stimulation site.
2.Individuals with a family history of epileptic seizures.
3.Individuals taking medications that act on the central nervous system or are known to increase the risk of epileptic seizures.
4.Individuals with a history of adverse reactions to electrical stimulation.
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kyoto University
Division name
Department of Human Health Sciences, Graduate School of Medicine
Zip code
6z068507
Address
53 Shogoin Kawara-machi, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-3963
yamaguchi.tomofumi.3i@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kyoto University
Division name
Department of Human Health Sciences, Graduate School of Medicine
Zip code
6068507
Address
53 Shogoin Kawara-machi, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-3963
Homepage URL
yamaguchi.tomofumi.3i@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin Kawara-machi, Sakyo-ku, Kyoto 606-8507, JAPAN
Tel
075-366-7618
ethcom@kuhp.kyoto-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
京都大学大学院医学研究科人間健康科学系専攻（京都府）
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University (Kyoto)
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | 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=R000072623
