UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comprehensive mapping of higher brain function by means of high frequency electrical cortical stimulation and event related potential
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Akio Ikeda
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Epilepsy, Movement Disorders and Physiology
Address	Kawaharacho54, Shogoin, Sakyo, Kyoto
TEL	075-751-3662
Email	akio@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Akihiro Shimotake
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Neurology
Address	Kawaharacho54, Shogoin, Sakyo, Kyoto
TEL	075-751-3772
Homepage URL
Email	smtk@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine Department of Epilepsy, Movement Disorders and Physiology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006233