UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical application of stereotactic intracranial depth electroencephalogram.
Title of the study (Brief title)	Clinical application of stereotactic intracranial depth electroencephalogram.
Region	Japan

Condition
Condition	refractory epilepsy
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal a seizure onset zone
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To improve a treatment outcome
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	Device,equipment
Interventions/Control_1	To reveal a seizure onset zone by using stereotactic depth electroencephalogram
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	16 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1:Drug resistant refractory epilepsy 2:Surgical removal of epileptic core is needed 3:Hard to detect the seizure onset zone despite consideration of several non-invasive study outcomes 4:informed consent
Key exclusion criteria	1:Having a uncontrollable respiratory or circulatory diseases 2:compromised 3:Cant have a medical examination till 2 years after 4:Having a severe cognitive dysfunction 5:Psychological intolerance of intracranial EEG implantation 6:Afraid of safety due to hyper motor seizure 7:Cant scan MRI
Target sample size	5

Research contact person
Name of lead principal investigator	Susumu Miyamoto
Organization	Kyoto university hospital
Division name	Neurosurgery
Address	54 Shogoin Kawahara-cho Sakyo-ku, Kyoto
TEL	075-751-3653
Email	miy@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yukihiro Yamao
Organization	Kyoto university hospital
Division name	Neurosurgery
Address	54 Shogoin Kawahara-cho Sakyo-ku, Kyoto
TEL	075-751-3653
Homepage URL
Email	yyamao@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto university hospital
Institute
Department

Funding Source
Organization	National institute for Physiological Sciences Non-linear Oscillology
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 12 Day
Anticipated trial start date	2016 Year 09 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	2016 Year 05 Month 12 Day
Last modified on	2018 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025687