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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024844
Receipt No. R000028486
Scientific Title Study of correlation between bold signal and cerebral blood flow in resting state
Date of disclosure of the study information 2016/11/15
Last modified on 2019/05/20

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Basic information
Public title Study of correlation between bold signal and cerebral blood flow in resting state
Acronym Correlation between bold signal and cerebral blood flow in resting state
Scientific Title Study of correlation between bold signal and cerebral blood flow in resting state
Scientific Title:Acronym Correlation between bold signal and cerebral blood flow in resting state
Region
Japan

Condition
Condition Normal subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate a relationship between functional MRI signal (BOLD signal) and cerebral blood flow signal (ASL signal) in a resting state.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Spatial correlative relation and timewise correlative relation between bold signal and cerebral blood flow (ASL signal)
Key secondary outcomes

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 Sensory stimulation
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
20 years-old <=
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria Healthy individuals who have the ability to provide informed consent.
Key exclusion criteria 1. History of severe systematic/CNS disease.
2. Drug and/or alcoholic abuse.
3. Not adaptable for MRI scanning (e.g. metallic devices, claustrophobia, nyctophobia)
4. Pregnancy
5. Operator's decision as not suitable for this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Ikoma
Organization National Institute of Radiological Sciences, QST
Division name Molecular Imaging and Theranostics
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba
TEL 043-206-3230
Email ikoma.yoko@qst.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuko Suzuki
Organization National Institute of Radiological Sciences, QST
Division name Assistance division of clinical research
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba
TEL 043-206-3025
Homepage URL
Email suzuki.kazuko@qst.go.jp

Sponsor
Institute National Institute of Radiological Sciences, QST
Institute
Department

Funding Source
Organization National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization Other
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
2016 Year 11 Month 15 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 Completed
Date of protocol fixation
2016 Year 10 Month 28 Day
Date of IRB
2016 Year 11 Month 02 Day
Anticipated trial start date
2016 Year 11 Month 15 Day
Last follow-up date
2019 Year 03 Month 27 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 15 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028486

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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