UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013895 |
|---|---|
| Receipt number | 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 12:03:04 |
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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
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
| 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
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
heike@kuhp.kyoto-u.ac.jp
Public contact
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
takeo819@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015640
