UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036075
Receipt number 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 2019/12/26 09:46:47

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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 Jun
Middle name
Last name Natsume

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Developmental Disability Medicine

Zip code

466-8560

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 Masahiro
Middle name
Last name Kawaguchi

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code

466-8560

Address

65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, JAPAN

TEL

052-744-2295

Homepage URL


Email

mkawaguchi@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



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

Nagoya University Ethics Review Committee

Address

65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, JAPAN

Tel

052-744-2061

Email

ethics@med.nagoya-u.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

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

Enrolling by invitation

Date of protocol fixation

2019 Year 03 Month 01 Day

Date of IRB

2019 Year 05 Month 29 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2029 Year 03 Month 31 Day

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 12 Month 26 Day



Link to view the page

Value
https://center6.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