UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment the cerebral circulation with use of resting state functional Magnetic resonance imaging
Title of the study (Brief title)	Assessnent the cerebral circulation with use of rsfMRI
Region	Japan

Condition
Condition	cerebrovascular disease
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Searching the biomarker about cerebral blood flow in rsfMRI.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lag of BOLD signal amplitude of BOLD signal
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	cerebrovascular disease(arteriosclerotic disease)
Interventions/Control_2	cerebrovascular disease(Moyamoya disease)
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	15 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are suspected falling cerebrovascular disease by CT,MRI,SPECT,PET.
Key exclusion criteria	(1) Patients who cannot be had MRI on head without a sedatative drug. (2)Patients who cannot be had MRI on head because of their bad general condition.
Target sample size	30

Research contact person
Name of lead principal investigator	Susumu Miyamoto
Organization	Kyoto University Graduate School of Medicine
Division name	Neurosurgery
Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL	075-751-3111
Email	miy@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Sei Nishida
Organization	Kyoto University Graduate School of Medicine
Division name	Neurosurgery
Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL	075-751-3111
Homepage URL
Email	sei813@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Neurosurgery, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Grants-in-aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2014 Year 11 Month 18 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 11 Month 15 Day
Anticipated trial start date	2014 Year 11 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 18 Day
Last modified on	2016 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018262