UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050194 |
|---|---|
| Receipt number | R000057163 |
| Scientific Title | Visualizing the neural representation of mental images using 7T MRI scanner |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/01/31 15:33:52 |
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Basic information
Public title
Visualizing the neural representation of mental images using 7T MRI scanner
Acronym
Visualizing the neural representation of mental images using 7T MRI scanner
Scientific Title
Visualizing the neural representation of mental images using 7T MRI scanner
Scientific Title:Acronym
Visualizing the neural representation of mental images using 7T MRI scanner
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to detect and quantify neural representations common across perception and imagery and to elucidate the neural basis. We measure brain activity from healthy subjects using a 7T MRI scanner and predict (decode) the contents of perception and imagery by applying machine learning-based statistical pattern analysis to the measured brain activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prediction performance of decoding models using fMRI signals
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
We use a 7T MRI scanner which has not been approved by (former) Pharmaceutical Affairs Law to measure brain activity. Measurements with the scanner are taken over multiple days, but the scanning time per subject per day is limited to 2 hours or less.
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
1. Subject who has provided written consent to participate in this study.
Key exclusion criteria
1. Cardiac pacemaker users
2. Users of cerebrovascular clips
3. Users of electrical nerve stimulators
4. Users of implantable pumps
5. Subjects with metal fragments remaining in the body
6. Those who are currently pregnant or suspected of being pregnant
7. Persons with tattoos (including tattoo-style eyeliner, etc.)
8. Persons with metal plates or screws in their body due to fractures or other orthopedic repairs
9. Claustrophobia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukiyasu |
| Middle name | |
| Last name | Kamitani |
Organization
Graduate school of informatics, Kyoto university
Division name
Neuroinformatics group, Department of intelligence science and technology
Zip code
606-8303
Address
Kyoto University Yoshida Medicine Campus, Yoshida-tachibanacho, Sakyo-ku, Kyoto
TEL
0757539133
kamitani@i.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukiyasu |
| Middle name | |
| Last name | Kamitani |
Organization
Graduate school of informatics, Kyoto university
Division name
Neuroinformatics group, Department of intelligence science and technology
Zip code
606-8303
Address
Kyoto University Yoshida Medicine Campus, Yoshida-tachibanacho, Sakyo-ku, Kyoto
TEL
0757539133
Homepage URL
kamitani@i.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
0757534680
ethcom@kuhp.kyoto-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
| 2023 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057163
