UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027949 |
|---|---|
| Receipt number | R000032016 |
| Scientific Title | clinical investigation of brain microstructure of moyamoya disease |
| Date of disclosure of the study information | 2017/06/27 |
| Last modified on | 2019/06/29 10:14:49 |
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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
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
| 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
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
shara.nsrg@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental Univeristy
Institute
Department
Personal name
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032016
