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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042386
Receipt No. R000048385
Scientific Title Understanding of neural representations of mental images
Date of disclosure of the study information 2020/11/09
Last modified on 2020/11/09

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Basic information
Public title Understanding of neural representations of mental images
Acronym Understanding of neural representations of mental images
Scientific Title Understanding of neural representations of mental images
Scientific Title:Acronym Understanding of neural representations of mental images
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, imagery, and dreaming, and to elucidate the neural basis of them.
To this end, we measure brain activity from healthy subjects using fMRI, and predict (decode) the contents of perception, imagery and dreaming 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
Medicine
Interventions/Control_1 Orexin receptor antagonist 20mg
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.
2. Subject who has difficulty falling asleep repeatedly and is interviewed by doctors and pharmacists.
Key exclusion criteria 1. Subject with contraindications to MRI
2. Pregnant or suspected of being pregnant.
3. Claustrophobia
4. Subject who suffer from sleep disorders
5. Subject has had symptoms associated with an abnormal sensitivity to components of orexin receptor antagonist
6. Subject who is prescribed CYP3A inhibitory drugs.
Target sample size 50

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 Department of intelligence science and technology
Zip code 606-8303
Address Kyoto University Yoshida Medicine Campus, Yoshida-tachibanacho, Sakyo-ku, Kyoto
TEL 0757539133
Email 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 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
Email kamitani@i.kyoto-u.ac.jp

Sponsor
Institute Kyoto university
Institute
Department

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
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 0757534680
Email 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
2020 Year 11 Month 09 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
2020 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2023 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
2020 Year 11 Month 09 Day
Last modified on
2020 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048385

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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