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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043718
Receipt No. R000049914
Scientific Title Dense sampling MRI and brain-behavior relationships
Date of disclosure of the study information 2021/03/23
Last modified on 2021/11/26

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Basic information
Public title Dense sampling MRI and brain-behavior relationships
Acronym Dense sampling MRI
Scientific Title Dense sampling MRI and brain-behavior relationships
Scientific Title:Acronym Dense sampling MRI
Region
Japan

Condition
Condition Healthy control
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine longitudinal changes in brain-behavior relationships
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Longitudinal changes in MRI indices and psychological test indices
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 text/audio-visual learning, physical exercise
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
60 years-old >
Gender Male
Key inclusion criteria 1.Those who have the ability to give consent for participation in this study and who can read and understand the explanatory documents.
2.The native language of the participant must be Japanese.
Key exclusion criteria 1) Patients with a history of or complications from organic brain disease (head injury, apparent stroke, etc.) 2) Patients with complications from mental or neurological disease (including drug dependence, etc.)
2) Patients with concomitant psychiatric or neurological disorders (including drug dependence, etc.). 3) Patients with complications of serious diseases or a history of such diseases.
3. those who have complications of serious diseases, or those who have a history of such diseases and are judged by the physician who is a researcher of the Quantitative Research Institute, etc., to be unsuitable for this research. 4. those who are pregnant or have the possibility of pregnancy.
Women who are pregnant or have the potential to become pregnant. 5.
Those who have pacemakers or internal metals (brain clips, bolts, etc.). 6.
Those who have tattoos (including tattoos and art makeup). 7.
Those who are claustrophobic. 8.
Those who are color blind. 9.
9. those who are deemed unsuitable as research subjects by the researchers of the ILCAA due to their inability to follow or understand the instructions of the researchers.
A person who is judged by a physician as an inappropriate research subject for any other reason.
Target sample size 1

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Matsuyoshi
Organization National Institutes for Quantum and Radiological Science and Technology
Division name National Institute of Radiological Sciences
Zip code 263-8555
Address 4-9-1 Anagawa, Inage, Chiba 263-8555, Japan
TEL +81-43-206-3249
Email matsuyoshi.daisuke@qst.go.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Matsuyoshi
Organization National Institutes for Quantum and Radiological Science and Technology
Division name National Institute of Radiological Sciences
Zip code 263-8555
Address 4-9-1 Anagawa, Inage, Chiba 263-8555, Japan
TEL +81-43-206-3249
Homepage URL
Email matsuyoshi.daisuke@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Institutes for Quantum and Radiological Science and Technology Certified Review Board
Address 4-9-1 Anagawa, Inage, Chiba 263-8555, Japan
Tel 043-206-4706
Email helsinki@qst.go.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
2021 Year 03 Month 23 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 No longer recruiting
Date of protocol fixation
2021 Year 03 Month 12 Day
Date of IRB
2021 Year 03 Month 12 Day
Anticipated trial start date
2021 Year 03 Month 12 Day
Last follow-up date
2024 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
2021 Year 03 Month 23 Day
Last modified on
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049914

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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