UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059757 |
|---|---|
| Receipt number | R000067399 |
| Scientific Title | Investigating the neural basis of interoceptive sensation and behavioral change using transcutaneous auricular vagus nerve stimulation (taVNS) |
| Date of disclosure of the study information | 2025/11/13 |
| Last modified on | 2025/11/13 12:44:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigating the neural basis of interoceptive sensation and behavioral change using transcutaneous auricular vagus nerve stimulation (taVNS)
Acronym
Investigating the neural basis of interoceptive sensation and behavioral change using transcutaneous auricular vagus nerve stimulation (taVNS)
Scientific Title
Investigating the neural basis of interoceptive sensation and behavioral change using transcutaneous auricular vagus nerve stimulation (taVNS)
Scientific Title:Acronym
Investigating the neural basis of interoceptive sensation and behavioral change using transcutaneous auricular vagus nerve stimulation (taVNS)
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study, which non-invasively stimulates the vagus nerve to modulate interoception, is twofold:
1) To examine whether the enhancement of interoception strengthens altruistic behavior, and to elucidate the underlying mechanism of this transformation, through the induction of neuroplasticity achieved by adding transcutaneous auricular Vagus Nerve Stimulation (taVNS) to cognitive training.
2) To clarify the neural basis by investigating changes in brain activity and structural connectivity resulting from the respective and interactive effects of the known taVNS intervention and conventional cognitive training intervention.
The future outlook of this research is to provide a novel approach that contributes to the alleviation of depression and anxiety symptoms. Specifically, by focusing on the effects of altruistic behavior on mental health and exploring the potential for interoception enhancement to promote such behavior, we aim to contribute to the development of new therapies. This study holds interdisciplinary significance, encompassing psychological, neuroscientific, and clinical medical perspectives.
Basic objectives2
Others
Basic objectives -Others
Assessment of Intervention Effects
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The following assessments will be performed before and after the 5-day intervention:
Altruistic behavior measures
Change in brain MRI images
Key secondary outcomes
State Trait Anxiety Inventory Japanese version and Social Anxiety Disorder Scale Japanese version
The Center for Epidemiologic Studies Depression Scale Japanese version
Rate of change in Heart Rate
Heartbeat Counting Task
Metacognition Task
Executive Function Measurement
Social Value Orientation
Multidimensional Assessment of Interoceptive Awareness Japanese version
Japanese version of the Patient Health Questionnaire 15
Wellbeing scales
Positive Affect Negative Affect Scale
Japanese version
Psychological Wellbeing Japanese version
Cantrils ladder
Satisfaction with Life Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Cognitive behavioral Training of Interoception:
The interoception training task (approx. 30 minutes) using a PC program will be administered once daily for 5 consecutive days.
Interventions/Control_2
taVNS stimulation:
30 minutes of taVNS will be administered once daily for 5 consecutive days.
Interventions/Control_3
Cognitive behavioral Training of Interoception + taVNS stimulation:
The interoception training task (approx. 30 minutes) using a PC program and 30 minutes of taVNS stimulation will be administered simultaneously, once daily for 5 consecutive days.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged 18 to 59 years at the time of informed consent.
2) Healthy adults with no regular hospital visits or medication use.
Key exclusion criteria
Behavioral Experiments
Individuals with a cochlear implant, cardiac pacemaker, or implanted Vagus Nerve Stimulator (VNS).
Individuals with an injury to the auricular area (ear).
Individuals who have undergone a cerebrospinal fluid (CSF) shunt procedure.
Individuals with a diagnosis of glaucoma.
Smokers.
Individuals with frequent cardiac arrhythmias.
Individuals whose resting heart rate is consistently below 60 beats per minute (bpm).
MRI Experiments
Individuals with a cochlear implant, cardiac pacemaker, or implanted VNS.
Individuals for whom MRI scanning poses a certain risk (e.g., tattoos, permanent make-up/cosmetic tattoos, claustrophobia, or other metallic implants/devices).
Individuals with an injury to the auricular area (ear).
Individuals who have undergone a cerebrospinal fluid (CSF) shunt procedure.
Individuals with a diagnosis of glaucoma.
Smokers.
Individuals with frequent cardiac arrhythmias.
Individuals whose resting heart rate is consistently below 60 beats per minute (bpm).
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ruri |
| Middle name | |
| Last name | Katsunuma |
Organization
National Center for Neurology and Psychiatry, National Institute of Mental Health
Division name
Department of Behavioral Medicine
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, Japan
TEL
042-341-2711
katsunuma@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Ruri |
| Middle name | |
| Last name | Katsunuma |
Organization
National Center for Neurology and Psychiatry, National Institute of Mental Health
Division name
Department of Behavioral Medicine
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, Japan
TEL
042-341-2711
Homepage URL
katsunuma@ncnp.go.jp
Sponsor or person
Institute
National Center for Neurology and Psychiatry, National Institute of Mental Health
Institute
Department
Personal name
Ruri Katsunuma
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tamagawa University Brain Science Institute
Tokyo Kasei Gakuin University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
Tel
042-341-2711
rinri-jimu@ncnp.go.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
玉川大学脳科学研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 13 | 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
| 2025 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067399
