UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062961 |
|---|---|
| Receipt number | R000072088 |
| Scientific Title | Elucidation of brain function during ASMR using functional magnetic resonance imaging |
| Date of disclosure of the study information | 2026/09/25 |
| Last modified on | 2026/09/25 13:58:47 |
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Basic information
Public title
A functional MRI study of brain function during ASMR viewing
Acronym: ASMR-fMRI Study
Acronym
ASMR-fMRI Study
Scientific Title
Elucidation of brain function during ASMR using functional magnetic resonance imaging
Scientific Title:Acronym
ASMR-fMRI Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate brain activity during ASMR video viewing using functional magnetic resonance imaging and to investigate its association with subjective ASMR intensity and relaxation.
Basic objectives2
Others
Basic objectives -Others
Investigation of brain activity and subjective responses during ASMR video viewing
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional connectivity between brain regions during ASMR video viewing assessed using functional magnetic resonance imaging (fMRI)
Key secondary outcomes
Subjective ASMR intensity and degree of relaxation assessed after ASMR video viewing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants select preferred and non-preferred ASMR videos from five ASMR videos presented in advance. During MRI scanning, participants view the selected ASMR videos while functional magnetic resonance imaging (fMRI) is performed. The total MRI scanning time is 15 minutes, and the intervention is conducted once.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults aged 18 to 30 years
2.Individuals who receive sufficient explanation of the study and provide written informed consent
Key exclusion criteria
1.Individuals with metallic implants or medical devices incompatible with MRI
2.Individuals unable to undergo MRI because of claustrophobia or other reasons
3.Individuals judged by the principal investigator to be unsuitable for participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Misuzu |
| Middle name | |
| Last name | Oishi |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Medical Technology, Department of Radiological Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata 950-3198, Japan
TEL
025-257-4455
misuzu-oishi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Misuzu |
| Middle name | |
| Last name | Oishi |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Medical Technology, Department of Radiological Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata 950-3198, Japan
TEL
025-257-4455
Homepage URL
misuzu-oishi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Ethics Review Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata 950-3198, Japan
Tel
025-257-4455
rinri@nuhw.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
| 2026 | Year | 09 | Month | 25 | 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
No plan to share individual participant data.
IPD sharing Plan description
There is no plan to share de-identified individual participant data with other researchers or institutions.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2031 | Year | 10 | Month | 20 | 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 | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072088
