UMIN-CTR Clinical Trial

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
Email	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
Email	tyanagisawa@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University, Department of neurosurgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049576