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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040241
Receipt No. R000045872
Scientific Title Study of brain changes due to stress and remote brain check-up: deep subcortical white matter high intensity grade, periventricular hyperintensity grade, enlargement of Virchow-Robin space, age, gender, BMI, hypertension, dyslipidemia, arrhythmia, stroke history, surgery history
Date of disclosure of the study information 2020/04/30
Last modified on 2020/04/26

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Basic information
Public title Study of brain changes due to stress and remote brain check-up
Acronym Study of brain changes due to stress and remote brain check-up
Scientific Title Study of brain changes due to stress and remote brain check-up: deep subcortical white matter high intensity grade, periventricular hyperintensity grade, enlargement of Virchow-Robin space, age, gender, BMI, hypertension, dyslipidemia, arrhythmia, stroke history, surgery history
Scientific Title:Acronym Study of brain changes due to stress and remote brain check-up: deep subcortical white matter high intensity grade, periventricular hyperintensity grade, enlargement of Virchow-Robin space, age, gender, BMI, hypertension, dyslipidemia, arrhythmia, stroke history, surgery history
Region
Japan

Condition
Condition deep subcortical white matter high intensity, periventricular hyperintensity, enlargement of Virchow-Robin space
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the change deep subcortical white matter lesions, periventricular hyperintensity, and enlargement of Virchow-Robin space in healthy adults.
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between deep subcortical white matter lesions, periventricular hyperintensity, enlargement of Virchow-Robin space and age, sex, BMI, hypertension, dyslipidemia, arrhythmia, stroke history, and surgical history.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes deep subcortical white matter high intensity grade periventricular hyperintensity, grade, enlargement of Virchow-Robin space grade
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
1 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Normal subjects undergoing brain check-up MRI
Key exclusion criteria Cases without brain check-up MRI
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name FUSAO
Middle name
Last name IKAWA
Organization Shimane Prefectural Central Hospital
Division name Department of Neurosurgery
Zip code 693-8555
Address 4-1-1 Himebara, Izumo City, Shimane, Japan
TEL 0853-22-5111
Email fikawa-nsu@umin.ac.jp

Public contact
Name of contact person
1st name FUSAO
Middle name
Last name IKAWA
Organization Shimane Prefectural Central Hospital
Division name Department of Neurosurgery
Zip code 693-8555
Address 4-1-1 Himebara, Izumo City, Shimane, Japan
TEL 0853-22-5111
Homepage URL
Email fikawa-nsu@umin.ac.jp

Sponsor
Institute Shimane Prefectural Central Hospital
Institute
Department

Funding Source
Organization Shimane Prefectural Central Hospital
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 Shimane Prefectural Central Hospital, Clinical Research and Trial Management Center
Address 4-1-1 Himebara, Izumo City, Shimane, Japan
Tel 0853-22-5111
Email chiken@spch.izumo.shimane.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
2020 Year 04 Month 30 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 09 Month 10 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2020 Year 04 Month 26 Day
Last modified on
2020 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045872

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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