UMIN-CTR Clinical Trial

Basic information
Public title	clinical investigation of brain microstructure of moyamoya disease
Acronym	diffusion MRI of Moyamoya Disease
Scientific Title	clinical investigation of brain microstructure of moyamoya disease
Scientific Title:Acronym	diffusion MRI of Moyamoya Disease
Region	Japan

Condition
Condition	moyamoya disease
Classification by specialty	Neurosurgery Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the microstructural change of moyamoya disease using neurite orientation dispersion and density imaging (NODDI) and saturated magnetization transfer metric(MTsat)
Basic objectives2	Others
Basic objectives -Others	1. To clarify the relationship of neurocognitive function and brain microstructure by comparing MRI parameters with scores of neurophysiological tests 2. To clarify the effect of chronic ischemia on brain microstructure by comparing MRI of patients with moyamoya disease and of age-sex matched normal healthy volunteers. 3. To clarify the relationship of cerebral metabolic and brain microstructure by comparing diffusion MRI and 15Ogas PET
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Comparing MRI parameters (ADC, FA, Vic, Viso and OD of NODDI, and MTsat) with scores of neurophysiological tests( WISC or WAIS, WCST, stroop test, word fluency test, TMT, and the BIg Five Personal Inventory or NEO-FFI)
Key secondary outcomes	2. Comparing MRI parameters (ADC, FA, Vic, Viso and OD of NODDI) of patients with moyamoya disease and of age-sex matched normal healthy volunteers. 3. Comparing MRI parameters (ADC, FA, Vic, Viso and OD of NODDI and MTsat) and 15Ogas PET (CBF, CBV, OEF, MTT and CMRO2).

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
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Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) inclusion criteria of patients: 1. 6 to 64 years old who can undergo MRI without sedative agents 2. diagnosed as bilateral or unilateral moyamoya disease according to diagnostic guidelines 3. no neurological deficit affecting the scores of neurophysiological tests (aphasia, agnosia etc) 4. modified Rankin scale of 0 to 2 5. informed consent obtained from patients and parents of patients under age (2) inclusion criteria of normal healthy volunteers: 1. 16 to 64 years old 2. no neurological deficit affecting the scores of neurophysiological tests (aphasia, agnosia etc) 3. modified Rankin scale of 0 to 3 4. no history of neurological disease
Key exclusion criteria	1. patients with quasi-moyamoya disease 2. contraindication of MRI examination (e.g. metal implants such as cardiac pacemaker) 3. brain lesion other than moyamoya disease affecting MRI parameters (e.g. brain tumor, venous angioma) 4. judged as inappropriate from other reasons (e.g. metal implants affecting MRI signals, clinical signs of depression or dementia, systemic disease such as terminal carcinoma, cirrhosis, renal insufficiency)
Target sample size	320

Research contact person
Name of lead principal investigator	1st name Tadashi Middle name Last name Nariai
Organization	Tokyo Medical and Dental Univeristy
Division name	Department of Neurosurgery
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyoku, Tokyo, 113-0034
TEL	03-3813-6111
Email	nariai.nsrg@tmd.ac.jp

Public contact
Name of contact person	1st name Shoko Middle name Last name Hara
Organization	Tokyo Medical and Dental Univeristy
Division name	Department of Neurosurgery
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyoku, Tokyo, 113-0034
TEL	03-3813-6111
Homepage URL
Email	shara.nsrg@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental Univeristy
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Radiology, Juntendo University Team of Neuroimaging, Tokyo Metropolitan Geriatric Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research IRB
Address	1-5-45, Yushima, Bunkyoku, Tokyo
Tel	03-5803-5612
Email	tiken.crc@tmd.ac.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	東京医科歯科大学医学部附属病院　脳神経外科

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 27 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
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 15 Day
Date of IRB	2017 Year 05 Month 28 Day
Anticipated trial start date	2017 Year 06 Month 15 Day
Last follow-up date	2029 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Under enrollment of participants and data analysis

Management information
Registered date	2017 Year 06 Month 27 Day
Last modified on	2019 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032016