UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023082 |
|---|---|
| Receipt number | 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 14:41:10 |
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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
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
shara.nsrg@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Department of Neurosurgery
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026552
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