UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042386
Receipt number R000048385
Scientific Title Understanding of neural representations of mental images
Date of disclosure of the study information 2020/11/09
Last modified on 2023/01/19 13:25:19

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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 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

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

Open public recruiting

Date of protocol fixation

2020 Year 08 Month 26 Day

Date of IRB

2020 Year 12 Month 08 Day

Anticipated trial start date

2020 Year 12 Month 08 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

2020 Year 11 Month 09 Day

Last modified on

2023 Year 01 Month 19 Day



Link to view the page

Value
https://center6.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