UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057683 |
|---|---|
| Receipt number | R000065229 |
| Scientific Title | Elucidating the Neural Mechanisms of Non-Pharmacological Interventions for Nausea: A Neuroscientific Approach |
| Date of disclosure of the study information | 2025/04/22 |
| Last modified on | 2025/04/22 15:35:03 |
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Basic information
Public title
PC6 stimulation : A Neuroscientific Approach
Acronym
PC6 stimulation : A Neuroscientific Approach
Scientific Title
Elucidating the Neural Mechanisms of Non-Pharmacological Interventions for Nausea: A Neuroscientific Approach
Scientific Title:Acronym
PC6 stimulation
Region
| Japan |
Condition
Condition
Postoperative nausea and vomiting
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of acupressure stimulation at the Neiguan (PC6) point on brain activity in healthy adult volunteers, using functional magnetic resonance imaging (fMRI). Specifically, we hypothesize that PC6 stimulation will induce changes in cerebral blood flow in the prefrontal cortex, amygdala, and medullary vomiting center. Additionally, we will examine whether the magnitude of signal changes differs between individuals with high and low risk factors for postoperative nausea and vomiting (PONV).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of fMRI and sMRI Data Obtained Using a 3T GE SIGNA Architect at Kagawa University Hospital MRI Facility, with and without Neiguan (PC6) Stimulation
Key secondary outcomes
Analysis of the Correlation Between fMRI and sMRI Responses to Neiguan (P6) Stimulation and Apfel Score
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Recruitment will take place at the researcher's affiliated institution between the date of approval by the ethics committee and March 31, 2028, targeting healthy adult volunteers who are willing to participate.
Participants must meet all of the inclusion criteria and must not fall under any of the exclusion criteria.
Eligible participants are healthy adult volunteers aged 20 years or older who have provided written informed consent to participate in this study.
Key exclusion criteria
Volunteers with severe systemic complications, such as heart failure, renal failure, liver failure, or respiratory failure.
Volunteers with severe mental disorders or associated psychiatric symptoms.
Volunteers with a history of claustrophobia or nyctophobia.
Volunteers with metal implants in their bodies.
Pregnant women.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | SHIRAISHI |
| Middle name | |
| Last name | REN |
Organization
Kagawa University Hospital
Division name
Department of Anesthesiology and pain management clinic
Zip code
761-0793
Address
1750-1 Ikedo, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
shiraishi.ren@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | SHIRAISHI |
| Middle name | |
| Last name | REN |
Organization
Kagawa University Hospital
Division name
Department of Anesthesiology and pain management clinic
Zip code
761-0793
Address
1750-1 Ikedo, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
Homepage URL
shiraishi.ren@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Yuichi Ogino's (KAKENHI) (22K09087) and Research Grant Donation Yuichi Ogino" & Takahiro Kakeda (KAKENHI) (23H03185)
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
Kagawa University Hospital
Address
1750-1 Ikedo, Miki-cho, Kita-gun, Kagawa, Japan
Tel
087-898-5111
shiraishi.ren@kagawa-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
| 2025 | Year | 04 | Month | 22 | 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
| 2023 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing in particular
Management information
Registered date
| 2025 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065229
