UMIN-CTR Clinical Trial

Basic information
Public title	A study of visual cognition
Acronym	A study of visual cognition
Scientific Title	A study of visual cognition
Scientific Title:Acronym	A study of visual cognition
Region	Japan

Condition
Condition	Normal volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine visual cognition and underlying mechanisms using physiological measurements including EEG and eye tracking systems.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Performance in visual tasks and EEG data will be examined
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	40 years-old >
Gender	Male and Female
Key inclusion criteria	A person who has normal or corrected-to-normal vision
Key exclusion criteria	A person who has had brain disease A person who has had substance dependence A person who has had psychiatric disorders A person who has had severe body disease A person who is regarded as ineligible for participation by a researcher /doctor
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Makiko Middle name Last name Yamada
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	Department of Functional Brain Imaging Research
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-3425
Email	yamada.makiko@qst.go.jp

Public contact
Name of contact person	1st name Kazuhisa Middle name Last name Shibata
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	Department of Functional Brain Imaging Research
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-3425
Homepage URL
Email	shibata.kazuhisa@qst.go.jp

Sponsor
Institute	National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Address	4-9-1 Anagawa, Inage, Chiba
Tel	043-206-4706
Email	helsinki@qst.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	2018 Year 11 Month 02 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	60
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	Completed
Date of protocol fixation	2018 Year 10 Month 31 Day
Date of IRB	2018 Year 10 Month 31 Day
Anticipated trial start date	2019 Year 06 Month 11 Day
Last follow-up date	2019 Year 09 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Participants are asked to perform simple visual tasks based on visual stimuli presented on a computer display. Performance in the task and physiological data are measured during the task.

Management information
Registered date	2018 Year 11 Month 02 Day
Last modified on	2019 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039625