UMIN-CTR Clinical Trial

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

moyamoya disease

Classification by specialty

Neurosurgery	Adult	Child

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Medical and Dental Univeristy

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Department of Radiology, Juntendo University
Team of Neuroimaging, Tokyo Metropolitan Geriatric Hospital

Name of secondary funder(s)

Organization

Clinical Research IRB

Address

1-5-45, Yushima, Bunkyoku, Tokyo

Tel

03-5803-5612

Email

tiken.crc@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科歯科大学医学部附属病院　脳神経外科

Date of disclosure of the study information

2017

Year

06

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Under enrollment of participants and data analysis

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