UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028817
Receipt number R000032964
Scientific Title The study of associations and interactions among gene, brain, cognitive functions, physical data, blood data, and daily habit
Date of disclosure of the study information 2017/08/25
Last modified on 2022/08/29 15:56:05

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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 or person

Institute

Tohoku university

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032964


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name