UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062847 |
|---|---|
| Receipt number | R000059809 |
| Scientific Title | Invastigation of brain nerve-interoceptive response induced by different body perception in real and virtual space |
| Date of disclosure of the study information | 2026/09/08 |
| Last modified on | 2026/09/08 14:20:39 |
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Basic information
Public title
Invastigation of brain nerve-interoceptive response induced by different body perception in real and virtual space
Acronym
brain nerve-interoceptive response in real and virtual space
Scientific Title
Invastigation of brain nerve-interoceptive response induced by different body perception in real and virtual space
Scientific Title:Acronym
brain nerve-interoceptive response in real and virtual space
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to elucidate how the basic dynamics of brain nerves and visceral reactions that occur during human body recognition and perception/recognition of objects differ between virtual and real spaces.
Basic objectives2
Others
Basic objectives -Others
In this project, we will (1) use healthy adults to reproduce psychological phenomena that occur on a daily basis (2) using experimental stimuli, and extract brain responses corresponding to information processing during those events. The purpose is to (4)clarify whether specific cranial nerves, internal organs, and biological reactions can be observed (3) compared with stimulation that does not introduce psychological phenomena.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will confirm how potential fluctuations obtained by scalp electroencephalogram measurements and brain images obtained by MRI imaging change in response to the presentation of specific sensory information.
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
In order to make people aware of the environment in the virtual space, we use a 3D space with a laboratory, a 3D model of a virtual room, or the avatars and objects of ourselves and others (desks, chairs, etc.) that exist there. Visual information and natural sounds heard in the environment (such as the sound of something touching) are presented as auditory information on a computer display, HMD, speaker, or headphones. The material is brought into contact with one or several locations selected through experiments among the fingers, palms, backs of hands, arms, shoulders, backs, and feet. When creating a pseudo-tactile experience without contacting the material, a bone conduction speaker (SOUNDBONE, GD-SBM, Golden Dance) and a vibration stimulator (mini PTS system, Dancer Design, UK) are used.Moreover, 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
Those who meet the following [research subject application conditions]
-Healthy adults between 18 and 40 years old
-Persons who can obtain written consent from the individual to participate in the research freely.
-Those who have sufficient physical strength to sit and stand from a chair by themselves.
-Persons with no history of cardiovascular disease such as stroke or ischemic heart disease.
-Height: 145-190cm, weight: 90kg or less, hip width: 40cm or less (due to restrictions on equipment installation on the fMRI bed)
-Handed hand: Right-handed (not corrected to be right-handed) (because brain reactions differ depending on the handedness).
-Persons without hearing impairment.
-Persons with no physical injuries (minor scratches, etc. may participate depending on the situation).
-Persons who do not have any metal objects in their body, regardless of the material. (However, dental fillings and crowns are allowed. Implants are not allowed.) (Restrictions on fMRI imaging)
-Persons who have never had head surgery.
-Persons who do not have a history of claustrophobia or dark fear. (This is done in a closed room with the lights turned off)
Key exclusion criteria
Those who meet any of the following [exclusion conditions for research subjects] are not eligible.
[Not allowed] Women who are pregnant or may become pregnant
[Not allowed] Those who cannot maintain the same posture for a long time due to hernia etc.
[Not allowed] Those with a history of neuropathic symptoms such as sciatica.
[Not allowed] Those who are taking medicine. (Cold medicine, medicines that control the function of neurotransmitters, etc.)
[Not allowed] Persons with a history of neurological diseases including epilepsy.
Target sample size
480
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
3058566
Address
Ibaraki, Tsukuba, Higashi 1-1-1, Tsukuba Center 6
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
3058566
Address
Ibaraki, Tsukuba, Higashi 1-1-1, Tsukuba Center 6
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
Minister 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
| 2023 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 17 | 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
| 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=R000059809
