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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024710
Receipt No. R000028429
Scientific Title Study for database development of structural and functional brain 3-tesra MRI image for healthy control subjects
Date of disclosure of the study information 2016/11/04
Last modified on 2018/11/19

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Basic information
Public title Study for database development of structural and functional brain 3-tesra MRI image for healthy control subjects
Acronym Keio Normal Brain MRI database project
Scientific Title Study for database development of structural and functional brain 3-tesra MRI image for healthy control subjects
Scientific Title:Acronym Keio Normal Brain MRI database project
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this study is to develop normal brain MRI database of structural brain form and functional brain activity using a same MRI imaging protocols in healthy controls. We will also study demographics and cognitive functions of participants.Current data will be used as a healthy control to compare with patient groups with our clinical studies.
Basic objectives2 Others
Basic objectives -Others brain volume and activity
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Structural and functional MRI image
Key secondary outcomes background demographics and cognitive functions

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 Prevention
Type of intervention
Other
Interventions/Control_1 f-MRI
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
13 years-old <=
Age-upper limit
110 years-old >
Gender Male and Female
Key inclusion criteria 1. aged >=13years,<110years
2. normal cognitive function(MMSE >=24 or JART(IQ) >=70)
3. obtained written consent for participating the study

Key exclusion criteria 1. No history or current diagnosis of DSM-IV Axis I Disorders.
2. No organic brain lesions or major cognitive deficits at screening.
3. No severe or unstable medical illness at screening.
4. Contraindication to MRI (including cardiac pacemaker, claustrophobia).
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Tabuchi, MD, PhD
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3971
Email tabuchi@a8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Bun Yamagata, MD, PhD
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3971
Homepage URL
Email yamagata@a6.keio.jp

Sponsor
Institute Keio Neuropsychiatry Neuroimaging Group
Institute
Department

Funding Source
Organization Company of Advanced Telecommunications Research Institute International
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 慶應義塾大学医学部・病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 04 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
2016 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 04 Day
Last modified on
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028429

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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