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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006364
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute The department of neurosurgery,Kyoto University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007554

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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