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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017626
Receipt No. R000020424
Scientific Title Analysis for specific resting state functional connectivity of Moyamoya disease.
Date of disclosure of the study information 2015/05/20
Last modified on 2017/11/23

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Basic information
Public title Analysis for specific resting state functional connectivity of Moyamoya disease.
Acronym Analysis for specific resting state functional connectivity of Moyamoya disease.
Scientific Title Analysis for specific resting state functional connectivity of Moyamoya disease.
Scientific Title:Acronym Analysis for specific resting state functional connectivity of Moyamoya disease.
Region
Japan

Condition
Condition Moyamoya disease
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify specific changes for resting state networks in moyamoya disease, and to examine the relationship with neurocognitive impairment and the influence of vascular reconstructive surgery for this disease.
Basic objectives2 Others
Basic objectives -Others To detect specific changes for brain networks in moyamoya disease compared to healthy controls.

To examine the correlation between network changes and cognitive function.

To evaluate the influence of vascular reconstructive surgery for network changes.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes At the first phase of the study, MRI, resting state fMRI, IMP-SPECT, MEG, and neuropsychometric examination are performed in disease patients, and evaluated with comparison to the data-base of healthy controls.
Key secondary outcomes After 6 months, resting state fMRI and MEG are performed again. After 12 months, MRI, resting state fMRI, IMP-SPECT, MEG, and neuropsychometric examination are performed again. These longitudinal data are compared between the patient groups with/without surgical intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 MRI, IMP-SPECT, resting state fMRI, MEG, neuropsychometric exam will be performed on the patient who undergoes surgery at the beginning of the study and 12 months later.
MEG, resting state fMRI will be performed 6 months after the beginning of the study.
Interventions/Control_2 MRI, IMP SPECT, resting state fMRI, MEG, neuropsychometric exam will be performed on the patient who doesn't undergo surgery at the beginning of the study and 12 months later.
MEG, resting state fMRI will be performed 6 months after the beginning of the study.
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria The patient who are diagnosed as moyamoya disease rediographically and never performed surgical intervention.

The age between 18 and 60, at the first time for participating the study (gender is not required).

Laterality of disease is not required (including quasi moyamoya disease).

The patient who are independent in daily life(modified RS<=2).

No apparent intracranial infarction/hemorrhage scar expanding one cortical artery supplied area by radiographical examination(CT and/or MRI).

No neurological symptom which may influence on performance of neuropsychometric testing (aphasia, hemianopsia, agnosia, etc)

The patient who are able to understand the purpose of this study, and sign the documents after one's agreement on the informed consent (parent's signature is required in case of under 20 years old participants)
Key exclusion criteria The patient who can't understand the purpose of this study.

The patient who can't be performed MRI and/or MEG because of implanted metallic instrument/things inside one's body.

The patient who are not diagnosed as moyamoya disease by multiple physicians in this research by imaging studies.

The patient who are not adequate for participating in this study judged by the research physicians with some reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sho Okamoto
Organization Nagoya University Graduate school of medicine
Division name Department of Neurosurgery
Zip code
Address 65 Tsurumai chou, Showa ward, Nagoya city, Aichi prefecture
TEL 052-744-2353
Email soknouge@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Sakamoto
Organization Nagoya University Graduate school of medicine
Division name Department of Neurosurgery
Zip code
Address 65 Tsurumai chou, Showa ward, Nagoya city, Aichi prefecture
TEL 052-744-2353
Homepage URL
Email ota.shinji@c.mbox.nagoya-u.ac.jp

Sponsor
Institute Nagoya University graduate school of medicine
Department of neurosurgery
Institute
Department

Funding Source
Organization Nagoya University graduate school of medicine
Department of neurosurgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 05 Month 20 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 Open public recruiting
Date of protocol fixation
2015 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 20 Day
Last modified on
2017 Year 11 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020424

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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