UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006364 |
|---|---|
| Receipt number | R000007554 |
| Scientific Title | The study of functional brain network –Intraoperative cortico-cortical and subcortico-cortical evoked potential study- |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2011/09/17 08:21:51 |
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Basic information
Public title
The study of functional brain network –Intraoperative
cortico-cortical and subcortico-cortical evoked potential study-
Acronym
The study of functional brain network –Intraoperative
cortico-cortical and subcortico-cortical evoked potential study-
Scientific Title
The study of functional brain network –Intraoperative
cortico-cortical and subcortico-cortical evoked potential study-
Scientific Title:Acronym
The study of functional brain network –Intraoperative
cortico-cortical and subcortico-cortical evoked potential study-
Region
| Japan |
Condition
Condition
Brain tumor,epilepsy,and vascular disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To try new intraoperative monitoring method by researching functional brain network with cortico-cortical and subcortico-cortical evoked potentials
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neurological symptoms within 1 week after surgery
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Brain tumor,epileptic focus,or vascular disease around the brain lesion with function such as motor or language
Key exclusion criteria
1.Patients who disagree with this research
2.Pregnant women
3.Patiens who are under 15 years old or over 70 years old
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Miyamoto |
Organization
Kyoto University Hospital
Division name
Neurosurgery
Zip code
Address
54,Kawaramachi Shogoin Sakyoku, Kyoto
TEL
075-751-3459
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Yamao |
Organization
Kyoto University Hospital
Division name
Neurosurgery
Zip code
Address
54,Kawaramachi Shogoin Sakyoku, Kyoto
TEL
Homepage URL
Sponsor or person
Institute
The department of neurosurgery,Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2011 | Year | 09 | Month | 17 | Day |
Last modified on
| 2011 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007554
