UMIN-CTR Clinical Trial

Basic information
Public title	The study of associations and interactions among gene, brain, cognitive functions, physical data, blood data, and daily habit
Acronym	The study of associations and interactions among gene, brain, cognitive functions, physical data, blood data, and daily habit
Scientific Title	The study of associations and interactions among gene, brain, cognitive functions, physical data, blood data, and daily habit
Scientific Title:Acronym	The study of associations and interactions among gene, brain, cognitive functions, physical data, blood data, and daily habit
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To reveal associations and interactions among gene, brain, cognitive functions, physical data, blood data, and daily habit
Basic objectives2	Others
Basic objectives -Others	To reveal associations and interactions among gene, brain, cognitive functions, physical data, blood data, and daily habit
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EQSQ questionnaires, well being scale, GPS, TPS, envy tendency scale, affiliation tendency scale, trust scale, groupism scale, preoccupation scale, justice world scale, sex role eagalitalianism scale, identifity scale, love scale, future meditation scale, IRI scale, agency scale, Schizotypal Personality Questionnaire, BIS, thankful scale, psychopathy scale, Machiavellism scale, social comparison tendency scale, hardiness scale, psychopathy scale, a questionnaire about imagination, tiredness scale, TCI, NEO-FFI, CARRS, POMS, cognitive reflectivity-impulsiveness scale, guilty scale, self conciousness scale, cognitive desire, achievement motivation scale, need for uniqueness scale, natinalism scale, locus of control scale, sexual attitude scale, optimism scale, self efficacy scale, self handicapping scale, Japanese type A scale, learning motivation scale, dysexecutive questionnaire, scale regarding lonliness, daily habit questionnaires(family composition, parents age, allergy, family SES, toshinken sleep questionnaires, morningness-eveningness questionnaires, media habit, questionnaires for media addiction, life stress scale, physical activity questionnaire, drinking smoking scales, social support questionare, developmental environment, questionnaires for bullying, PBI, adolescents growing scales) food habit questiionaires, hair mineral,finger information, eye sight STAXI, critical thinking scale, Rosesnberg self esteem scale, Check list Strength,STAI, Beck's depression scale, paranoia checklist, percieved stress scale, delay discounting scale, GHQ30,QOL26,EQS computerized working memory tasks, Raven's advanced progressive matrix test, reading comprehension test, Tanaka's intelligence test type B, Stroop test, S-A creativity test, remote associate test, epigenetics, protemics, genetic information (polymorphism) brain volume, brain microstructurl property, cerebral blood flow, functional connectivitiy, brain activation
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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy right hand Japanese speaker
Key exclusion criteria	taking drugs history of traumatic brain injury neurological and psychiatric diseases metals in the body claustrophobia pregnancy
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Ryuta Middle name Last name Kawashima
Organization	IDAC, Tohoku University.
Division name	Advanced Brain Science
Zip code	980-8575
Address	4-1, Seiryo-cho, Sendai city, Aoba-ku
TEL	022-717-7988
Email	ryuta@idac.tohoku.ac.jp

Public contact
Name of contact person	1st name Hikaru Middle name Last name Takeuchi
Organization	IDAC, Tohoku University
Division name	Division of developmental cognitive neuroscience
Zip code	980-8575
Address	4-1, Seiryo-cho, Aoba-ku, Sendai city
TEL	022-717-8457
Homepage URL
Email	takehi@idac.tohoku.ac.jp

Sponsor
Institute	Tohoku university
Institute
Department

Funding Source
Organization	chizaisozokeihi, nintendo's collaborative research fund, kakenhi, donation of division of developmental cognitive neuroscience
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku university school of medicine, ethics committee
Address	Tohoku university school of medicine, Seiryo-cho 2-1, Aoba-ward, Sendai, Miyagi
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	2017 Year 08 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
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 25 Day
Date of IRB	2010 Year 03 Month 29 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2021 Year 04 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	investigating the associations among measures obtained in the cohort.

Management information
Registered date	2017 Year 08 Month 25 Day
Last modified on	2022 Year 08 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032964