UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024710 |
|---|---|
| Receipt number | 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 | 2022/10/28 11:32:55 |
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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 | Bun |
| Middle name | |
| Last name | Yamagata |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
yamagata@a6.keio.jp
Public contact
Name of contact person
| 1st name | Bun |
| Middle name | |
| Last name | Yamagata |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
yamagata@a6.keio.jp
Sponsor or person
Institute
Keio Neuropsychiatry Neuroimaging Group
Institute
Department
Personal name
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
Clinical and Translational Research Center
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
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
| 2016 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028429
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
