UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005492 |
|---|---|
| Receipt number | R000006233 |
| Scientific Title | Comprehensive mapping of higher brain function by means of high frequency electrical cortical stimulation and event related potential |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2016/04/22 22:36:20 |
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Basic information
Public title
Comprehensive mapping of higher brain function by means of high frequency electrical cortical stimulation and event related potential
Acronym
comprehensive mapping of higher brain function by means of HFECS and ERP
Scientific Title
Comprehensive mapping of higher brain function by means of high frequency electrical cortical stimulation and event related potential
Scientific Title:Acronym
comprehensive mapping of higher brain function by means of HFECS and ERP
Region
| Japan |
Condition
Condition
intractable partial epilepsy, brain tumor
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the method of mapping for higher brain function by combined use of event related potential and electrical cortical stimulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify the area related to the higher brain function, such as memory, jugement and language.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Recording of event related potential and direct electrical cortical stimulation under subdural electrodes implantation
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with intractable partial epilepsy or brain tumor, who undergo chronic implantation of subdural electrodes for presurgical evaluation of the resection of epileptic focus and give informed consent.
Key exclusion criteria
Those, who do not give informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Ikeda |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Epilepsy, Movement Disorders and Physiology
Zip code
Address
Kawaharacho54, Shogoin, Sakyo, Kyoto
TEL
075-751-3662
akio@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Shimotake |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
Kawaharacho54, Shogoin, Sakyo, Kyoto
TEL
075-751-3772
Homepage URL
smtk@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Department of Epilepsy, Movement Disorders and Physiology
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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
Management information
Registered date
| 2011 | Year | 04 | Month | 22 | Day |
Last modified on
| 2016 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006233
| Research Plan | |
|---|---|
| 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 |
