UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017900 |
|---|---|
| Receipt number | R000019985 |
| Scientific Title | Developement of biomarker and application for BMI using intracranial EEG |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2015/06/14 14:51:42 |
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Basic information
Public title
Developement of biomarker and application for BMI using intracranial EEG
Acronym
Development of ECoG BMI
Scientific Title
Developement of biomarker and application for BMI using intracranial EEG
Scientific Title:Acronym
Development of ECoG BMI
Region
| Japan |
Condition
Condition
Neurological disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Find a biomaker for neurological disease such as epilepsy using a long-term recording of intracranial EEG. Make a data abase of icEEG to find the biomaker and also to improve the efficacy of BMI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Accuracy to classify icEEG
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who agreed to join this study after the infromed concent.
Patient who was implanted the electrodes.
Key exclusion criteria
Patient who is judged not appropriate by the person in charge of this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKUFUMI YANAGISAWA |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
2-2 Yamadaoka Suita Osaka
TEL
06-6879-3652
tyanagisawa@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKUFUMI YANAGIASAWA |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
2-2 Yamadaoka Suita Osaka
TEL
06-6879-3652
Homepage URL
http://www.nsurg.med.osaka-u.ac.jp/
tyanagisawa@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
大阪大学医学部附属病院（大阪）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 15 | 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
Identification of biomarker of epilepsy and improvement of BMI accuracy
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 | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Identification of biomarker of epilepsy and improvement of BMI accuracy
Management information
Registered date
| 2015 | Year | 06 | Month | 14 | Day |
Last modified on
| 2015 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019985
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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