UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013180 |
|---|---|
| Receipt number | R000014806 |
| Scientific Title | Cognitive dysfunction Survey of Moyamoya |
| Date of disclosure of the study information | 2014/02/17 |
| Last modified on | 2014/02/17 20:09:27 |
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Basic information
Public title
Cognitive dysfunction Survey of Moyamoya
Acronym
COSMO-JAPAN study
Scientific Title
Cognitive dysfunction Survey of Moyamoya
Scientific Title:Acronym
COSMO-JAPAN study
Region
| Japan |
Condition
Condition
Moyamoya disease
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the radiological features and neurophysiological assessment in the patients with cognitive dysfunction in moyamoya disease.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Without primary outcomes
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with moyamoya disease (over 18 years old under 60 years old)
mRS under 3
without orgenic lesions assessed by CT or MRI
Key exclusion criteria
without neurological disorders affecting neurophysiological assessment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Miyamoto |
Organization
Kyoto University
Division name
Neurosurgery
Zip code
Address
Kytoto, Japan
TEL
075-751-3459
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Takagi |
Organization
Kyoto University
Division name
Neurosurgery
Zip code
Address
Kytoto, Japan
TEL
075-751-3459
Homepage URL
ytakagi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Kyoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2014 | Year | 02 | Month | 17 | 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
| 2013 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under enrollment
Management information
Registered date
| 2014 | Year | 02 | Month | 17 | Day |
Last modified on
| 2014 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014806
