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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036075
Receipt No. R000041097
Scientific Title Elucidation of neural network of healthy children by MRI analysis
Date of disclosure of the study information 2019/03/05
Last modified on 2019/03/04

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Basic information
Public title Elucidation of neural network of healthy children by MRI analysis
Acronym rs-fMRI of healthy children
Scientific Title Elucidation of neural network of healthy children by MRI analysis
Scientific Title:Acronym rs-fMRI of healthy children
Region
Japan

Condition
Condition healthy children
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate diversity of neural network of healthy children by MRI analysis.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes data of brain MRI
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
3 years-old <=
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria 1,healthy children with no neurological abnormality
2,chileren who got consent in document
Key exclusion criteria 1,intellectual disability
2,Developmental disability
3,history of severe head injury
4,history of brain disease
5,history of psychiatric disorde
6,applicable to contraindications of MRI such as metal not compatible with MRI, pregnancy and so on
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Natsume
Organization Nagoya University Graduate School of Medicine
Division name Department of Developmental Disability Medicine
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, JAPAN
TEL 052-744-2295
Email junnatsu@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Kawaguchi
Organization Nagoya University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, JAPAN
TEL 052-744-2295
Homepage URL
Email mkawaguchi@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 05 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will perform brain MRI(rs-fMRI,diffusion tensor image), and analyze the data by
dividing into groups according to age.

Management information
Registered date
2019 Year 03 Month 04 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041097

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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