UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062844 |
|---|---|
| Receipt number | R000058548 |
| Scientific Title | Investigation of brain responses related to physical sensations accompanied by mild pain stimuli |
| Date of disclosure of the study information | 2026/09/08 |
| Last modified on | 2026/09/08 12:07:38 |
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Basic information
Public title
Investigation of brain responses related to physical sensations accompanied by mild pain stimuli
Acronym
Brain responses to mild pain stimuli
Scientific Title
Investigation of brain responses related to physical sensations accompanied by mild pain stimuli
Scientific Title:Acronym
Brain responses to mild pain stimuli
Region
| Japan |
Condition
Condition
Not for specific disiease
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, (1) for healthy adult participants, (2) selective stimulation of nerve fibers to extract brain responses corresponding to specific fiber-related tactile comforts. The purpose of this study is to clarify whether (3) compairing to non nerve-fiber-specific stimulation, (4) specific waveforms can be found at specific latency and specific scalp site.
Basic objectives2
Others
Basic objectives -Others
Confirmation of appearance of neural response to specific stimulation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Confirm whether the waveforms obtained by scalp electroencephalography appear as a specific latent time corresponding to the activity of specific tactile-related nerve fibers, and identify their scalp distribution.
Key secondary outcomes
(1) Confirm whether the waveforms obtained by scalp electroencephalography increases or decreases in response to a specific sensitivity evaluation.
(2) Confirm whether the activity of specific nerve fibers and the sensitivity evaluation increase or decrease depending on the person's prior state (personality tendencies).
(3) Comfirm correlation between the reaction intensity (amplitude) of nerve fibers and the number of heartbeats or facial muscles.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using peripheral nerve electrical stimulator (PNS-5100; Japan manufactured by Koden) and its stimulation electrode (NM-983W; Using Japan manufactured by Kodensha), epidermal electric stimulations are delivered to participants.
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Healthy adults between 18 and 40 years old
-Those who can obtain written consent from the individual to participate in the research voluntarily.
-Those who are physically strong enough to stand and sit on a chair by themselves.
-People who have no history of cardiovascular disease such as stroke or ischemic heart disease.
-Height: 145-190cm, Weight: 90kg or less, Waist width: 40cm or less
-Handedness: Right-handed (those who have been corrected to be right-handed are not allowed).
-Those who have no hearing impairment.
-Those who have no injury to the body, mainly the left hand and left arm.
-Those who do not have any metal objects in their body, regardless of the material. (However, tooth fillings and crowns are permitted. Implants are not permitted.)
-Those who have never undergone head surgery.
-Those who do not have a history of claustrophobia or phobia of the dark.
Key exclusion criteria
-[Not allowed] Those who are pregnant or may be pregnant
-[Not allowed] Those who cannot maintain the same posture for a long time due to hernia.
-[Not allowed] Those who are taking medicine. (Cold medicines, medicines that control the function of neurotransmitters, etc.)
-[Not allowed] Those who are allergic to alcohol
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | KANAYAMA |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute (HIIRI)
Zip code
305-8566
Address
Tsukuba Center 6, Higashi 1-1-1, Tsukuba, Ibaraki
TEL
05035223376
kanayama.n@aist.go.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | KANAYAMA |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute (HIIRI)
Zip code
305-8566
Address
Tsukuba Center 6, Higashi 1-1-1, Tsukuba, Ibaraki
TEL
05035223376
Homepage URL
kanayama.n@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Environment and Safety Division, Life Science Experiments Room, Bioethics and Biosafety Management Office, Committee on Bioethics of Experiments involving humanderived materials
Address
Tsukuba Center 1, Higashi 1-1-1, Tsukuba, Ibaraki
Tel
029-861-2120
safe-life-ml@aist.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Suspended
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 28 | 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
Management information
Registered date
| 2026 | Year | 09 | Month | 08 | Day |
Last modified on
| 2026 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058548
