UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023082
Receipt No. R000026552
Scientific Title Clinical significance of diffusion MRI in patients with moyamoya disease
Date of disclosure of the study information 2016/07/12
Last modified on 2020/07/11 (Ver. 7)

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Basic information
Public title Clinical significance of diffusion MRI in patients with moyamoya disease
Acronym diffusion MRI of moyamoya disease
Scientific Title Clinical significance of diffusion MRI in patients with moyamoya disease
Scientific Title:Acronym diffusion MRI of moyamoya disease
Region
Japan

Condition
Condition moyamoya disease (children and adults)
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the clinical significance of diffusion MRI named neurite orientation dispersion and density imaging (NODDI) and intravoxel incoherent motion (IVIM) in patients with moyamoya disease.
Basic objectives2 Others
Basic objectives -Others 1. To clarify the relationship of neurocognitive function and brain microstructure by comparing diffusion MRI parameters with scores of neurophysiological tests
2. To clarify the effect of chronic ischemia on brain microstructure by comparing diffusion MRI of patients with moyamoya disease and of age-sex matched normal healthy volunteers.
3. To verify the cerebral perfusion model of diffusion MRI and to clarify the relationship of cerebral metabolic and brain microstructure by comparing diffusion MRI and 15Ogas PET
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1. Comparing diffusion MRI parameters (ADC, FA, Vic, Viso and OD of NODDI) 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 diffusion MRI (ADC, FA, Vic, Viso and OD of NODDI) of patients with moyamoya disease and of age-sex matched normal healthy volunteers.
3. Comparing diffusion MRI(D* and f map of IVIM, and ADC, FA, Vic, Viso and OD of NODDI) and 15Ogas PET (CBF, CBV, OEF 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 3
5. informed consent obtained from patients and parents of patients under age

(2) inclusion criteria of normal healthy volunteers:
1. 20 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
3. brain lesion other than moyamoya disease affecting MRI parameters (e.g. brain tumor, venous angioma)
4. judged as inappropriate participants by doctor-in-charge
Target sample size 200

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 University
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 University, Department of Neurosurgery
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Reserch Center
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 12 Day

Related information
URL releasing protocol https://kaken.nii.ac.jp/file/KAKENHI-PROJECT-16K19995/16K19995seika.pdf
Publication of results Published

Result
URL related to results and publications https://kaken.nii.ac.jp/file/KAKENHI-PROJECT-16K19995/16K19995seika.pdf
Number of participants that the trial has enrolled 31
Results 
This study revealed that patients with moyamoya disease suffer from chronic ischemic damage to the brain microstructure, i.e. decreased neurite density and simplified network complexity, and the degree of ischemic damage is related to neurocognitive dysfunction and the degree of hemodynamic and metabolic dysfunction. We also found that diffusion magnetic resonance imaging might be used to noninvasevely evaluate cerebral hemodynamic impairment in patients with moyamoya disease.
Results date posted
2020 Year 07 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 09 Month 01 Day
Baseline Characteristics 
Patients with moyamoya disease followed in our university hospital
Participant flow 
recruited to the study during hospitalization or at outpatient clinic
Adverse events 
None
Outcome measures 
1. relationship between brain microstructure and cognitive performance
2. difference of brain microstructure between patients with moyamoya disease and normal volunteers
3. relationship between hemodynamic and metabolic parameters of PET and brain microstructure
4. relationship between hemodynamic parameters of PET and hemodynamic parameters of IVIM
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 12 Month 22 Day
Date of IRB
2015 Year 12 Month 22 Day
Anticipated trial start date
2015 Year 12 Month 22 Day
Last follow-up date
2017 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Data analysis and publication completed

Management information
Registered date
2016 Year 07 Month 08 Day
Last modified on
2020 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026552