臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 26, 2019
Last modified on	Dec. 21, 2023
Trial ID	jRCTs052180166

Scientific Title	Clinical usage of Stereotactic electroencephalography (SEEG)
Public Title	Stereotactic electroencephalography (SEEG)

Completion date	Nov. 20, 2023
Result actual enrolment	4
Baseline Characteristics	Drug-resistent epilepy patients who were planned to perform focus resection
Participant flow	Four patients were included in this sudy, and streotactic electrode placement was performed in all four patients.
Adverse events	None
Outcome measures	SEEG was available in all four patients, and contributed to the detection of epileptic foci. In three out of four patients, seizure reduced after focus resection. Becase the drill sleeve for irrigation became recalled and SEEG has covered by insurance from April, 2020, the study has been completed.
Brief summary	SEEG was less invasive methods than subdural electrode placement. SEEG was useful in order to detect epileptic foci.
Date of posting of results summaries	Dec. 20, 2023
Date of the first journal publication of results	Oct. 10, 2018
URL hyperlink(s) related to results and publications	https://webview.isho.jp/journal/detail/abs/10.11477/mf.1436203839

Plan to share IPD	No
Plan description	Nothing
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs052180166

Contact for Scientific Queries	Name	Kikuchi Takayuki
	Affiliation	Kyoto University Graduate School of Medicine
	Address	54, ShogoinKawahara-cho, Sakyo-ku, Kyoto, Japan
	Telephone	+81-75-751-3459
	E-mail	tkik@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Yamao Yukihiro
	Affiliation	Kyoto University Graduate School of Medicine
	Address	54, ShogoinKawahara-cho, Sakyo-ku, Kyoto, Japan
	Telephone	+81-75-751-3459
	E-mail	yyamao@kuhp.kyoto-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 27, 2016
Actual date of first enrollment
Target sample size		5
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. 16-75 years of age 2. patients with medically intractable epilepsy 3. Need to focus resection 4. Difficulty in identification of epileptic focus by using conventional investigations 5. Understanding of the explanation and confirmation of the consent 6. patients in whom pre- and postoperative MRI can be performed
	Exclusion Criteria	1. patients with uncontrollable respiratory or cardiovascular diseases 2. compromised host 3. patients who will not be able to visit hospital 2 years after operation 4. Brain dysfunction or mental disorder 5. patients with hypermotor seizure 6. patients with pacemaker 7. patients with metals in the body that are not confirmed to perform MRI
	Age Minimum	16age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Epilepsy
Intervention(s)		None
Health Condition(s) Keyword		Epilepsy
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		To evaluate efficiency of stereotactic electroencephalogram by recording electrocorticogram and electrosubcorticogram
Secondary Outcome(s)		1) Identification of epileptic focus of the deep part of the brain 2) Improvement of results of epilepsy surgery

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kyoto University Certified Review Board
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN, Kyoto
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 04, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Dec. 21, 2023	(this page)	Changes
3	Mar. 27, 2023	Detail	Changes
2	May. 27, 2019	Detail	Changes
1	Mar. 26, 2019	Detail

List of change history