UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis for specific resting state functional connectivity of Moyamoya disease.
Title of the study (Brief title)	Analysis for specific resting state functional connectivity of Moyamoya disease.
Region	Japan

Condition
Condition	Moyamoya disease
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify specific changes for resting state networks in moyamoya disease, and to examine the relationship with neurocognitive impairment and the influence of vascular reconstructive surgery for this disease.
Basic objectives2	Others
Basic objectives -Others	To detect specific changes for brain networks in moyamoya disease compared to healthy controls. To examine the correlation between network changes and cognitive function. To evaluate the influence of vascular reconstructive surgery for network changes.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	At the first phase of the study, MRI, resting state fMRI, IMP-SPECT, MEG, and neuropsychometric examination are performed in disease patients, and evaluated with comparison to the data-base of healthy controls.
Key secondary outcomes	After 6 months, resting state fMRI and MEG are performed again. After 12 months, MRI, resting state fMRI, IMP-SPECT, MEG, and neuropsychometric examination are performed again. These longitudinal data are compared between the patient groups with/without surgical intervention.

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	MRI, IMP-SPECT, resting state fMRI, MEG, neuropsychometric exam will be performed on the patient who undergoes surgery at the beginning of the study and 12 months later. MEG, resting state fMRI will be performed 6 months after the beginning of the study.
Interventions/Control_2	MRI, IMP SPECT, resting state fMRI, MEG, neuropsychometric exam will be performed on the patient who doesn't undergo surgery at the beginning of the study and 12 months later. MEG, resting state fMRI will be performed 6 months after the beginning of the study.
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	The patient who are diagnosed as moyamoya disease rediographically and never performed surgical intervention. The age between 18 and 60, at the first time for participating the study (gender is not required). Laterality of disease is not required (including quasi moyamoya disease). The patient who are independent in daily life(modified RS<=2). No apparent intracranial infarction/hemorrhage scar expanding one cortical artery supplied area by radiographical examination(CT and/or MRI). No neurological symptom which may influence on performance of neuropsychometric testing (aphasia, hemianopsia, agnosia, etc) The patient who are able to understand the purpose of this study, and sign the documents after one's agreement on the informed consent (parent's signature is required in case of under 20 years old participants)
Key exclusion criteria	The patient who can't understand the purpose of this study. The patient who can't be performed MRI and/or MEG because of implanted metallic instrument/things inside one's body. The patient who are not diagnosed as moyamoya disease by multiple physicians in this research by imaging studies. The patient who are not adequate for participating in this study judged by the research physicians with some reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	Sho Okamoto
Organization	Nagoya University Graduate school of medicine
Division name	Department of Neurosurgery
Address	65 Tsurumai chou, Showa ward, Nagoya city, Aichi prefecture
TEL	052-744-2353
Email	soknouge@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yusuke Sakamoto
Organization	Nagoya University Graduate school of medicine
Division name	Department of Neurosurgery
Address	65 Tsurumai chou, Showa ward, Nagoya city, Aichi prefecture
TEL	052-744-2353
Homepage URL
Email	ota.shinji@c.mbox.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University graduate school of medicine Department of neurosurgery
Institute
Department

Funding Source
Organization	Nagoya University graduate school of medicine Department of neurosurgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	2015 Year 05 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 05 Month 12 Day
Anticipated trial start date	2015 Year 05 Month 25 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	2015 Year 05 Month 20 Day
Last modified on	2017 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020424