UMIN-CTR Clinical Trial

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