UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043420 |
|---|---|
| Receipt number | R000049576 |
| Scientific Title | Development of cortical mapping method |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2021/02/23 13:33:10 |
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Basic information
Public title
Study of cortical mapping method
Acronym
cortical mapping
Scientific Title
Development of cortical mapping method
Scientific Title:Acronym
cortical mapping
Region
| Japan |
Condition
Condition
A patient who will be undergoing cortical mapping using implanted electrodes
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
development of cortical mapping
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
safety of cortical mapping
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a patient who has implanted the subdural electrodes and will be undergoing cortical mapping
Key exclusion criteria
Those who are considered to be unable to perform the task.
Those who are judged unable to participate in this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Kishima |
Organization
Osaka University Graduate school of medicine
Division name
neurosurgery
Zip code
5650871
Address
2-2, Suita, Osaka, Japan
TEL
06-6879-3652
tyanagisawa@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takufumi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Osaka University
Division name
Institute for advanced co-creation studies
Zip code
5650871
Address
2-2, Suita, Osaka, Japan
TEL
06-6879-3652
Homepage URL
http://www2.med.osaka-u.ac.jp/nsurg/clinical/function
tyanagisawa@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Department of neurosurgery
Institute
Department
Personal name
Funding Source
Organization
JST
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
Osaka University Clinical Research Review Committee
Address
2-2 Suita, Osaka , Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2021 | Year | 12 | Month | 31 | 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
| 2021 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2021 | Year | 02 | Month | 23 | Day |
Last modified on
| 2021 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049576
