UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017626 |
|---|---|
| Receipt number | 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 17:37:52 |
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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
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
ota.shinji@c.mbox.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University graduate school of medicine
Department of neurosurgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020424
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
