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Recruitment status Terminated
Unique ID issued by UMIN UMIN000013895
Receipt No. R000015640
Scientific Title Research on functional brain development and pediatric developmental disabilities using electroencephalogram, magnetoencephalogram and magnetic resonance imaging.
Date of disclosure of the study information 2014/05/31
Last modified on 2015/11/07

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Basic information
Public title Research on functional brain development and pediatric developmental disabilities using electroencephalogram, magnetoencephalogram and magnetic resonance imaging.
Acronym Research on brain development and its impairment using EEG, MEG and MRI
Scientific Title Research on functional brain development and pediatric developmental disabilities using electroencephalogram, magnetoencephalogram and magnetic resonance imaging.
Scientific Title:Acronym Research on brain development and its impairment using EEG, MEG and MRI
Region
Japan

Condition
Condition Developmental disorders
Classification by specialty
Pediatrics Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate possibly altered functional brain network properties in patients with developmental disorders.
Basic objectives2 Others
Basic objectives -Others Functional brain imaging studies including Healthy participants.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Not applicable.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with genetic disorders harboring specific developmental characteristics, autistic disorders, attention deficit hyperactive disorders, and other developmental disorders. Healthy controls.
Key exclusion criteria For MRI, patients with implanted metallic or electrical devices.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshio Heike
Organization Kyoto University Graduate School of Medicine
Division name Pediatrics
Zip code
Address 54 Shogoinkawaharacho, Sakyo, Kyoto
TEL 075-751-3290
Email heike@kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takeo Kato
Organization Kyoto University Graduate School of Medicine
Division name Pediatrics
Zip code
Address 54 Shogoinkawaharacho, Sakyo, Kyoto
TEL 075-751-3290
Homepage URL
Email takeo819@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
2014 Year 05 Month 31 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 Terminated
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 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 Observational study including healthy controls.

Management information
Registered date
2014 Year 05 Month 07 Day
Last modified on
2015 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015640


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