臨床研究等提出・公開システム

Scientific Title	A registry study of anterior nucleus of thalamus stimulation therapy for refractory epilepsy (A registry study of anterior nucleus of thalamus stimulation therapy for refractory epilepsy)
Public Title	A registry study of anterior nucleus of thalamus stimulation therapy for refractory epilepsy

Contact for Scientific Queries	Name	Kishima Haruhiko
	Affiliation	Osaka University Hospital
	Address	Yamadaoka 2-15, Suita
	Telephone	+81-6-6879-3652
	E-mail	hkishima@nsurg.med.osaka-u.ac.jp
Contact for Public Queries	Name	Tani Naoki
	Affiliation	Osaka University Hospital
	Address	Yamadaoka 2-15, Suita
	Telephone	+81-6-6879-3652
	E-mail	n-tani@nsurg.med.osaka-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Oct. 10, 2024
Actual date of first enrollment
Target sample size		200
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with refractory epilepsy who have undergone surgery after being judged as suitable for surgery by a physician who has attended the Deep Brain Stimulation (DBS) for Epilepsy Techniques Course held by the Japanese Epilepsy Society and is capable of judgment and adjustment of indications. Patients who have given written consent to participate in the study.
	Exclusion Criteria	Persons deemed unsuitable by the principal investigator or principal investigator's assistant
	Age Minimum	No limit
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		intractable focal epilepsy
Intervention(s)
Health Condition(s) Keyword		intractable, drug resistant, focal epilepsy
Intervention(s) Keyword
Health Condition(s) Code		D004828
Intervention(s) Code
Primary Outcome(s)		seizure reducation rate, responder rate
Secondary Outcome(s)		Medications Developmental Status Mental Status Social Status Quality of Life (QOLIE-31) Memory (Rivermead Behavioral Memory Test) Mood (Beck Depression Inventory II) Adverse events, malfunctions

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Medtronic Japan Co., Ltd
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethical Review Board Osaka University Hospital
Address	2-2 Yamadaoka, Suita, Japan, Osaka
Telephone	+81-6-6210-8270
E-Mail	handai-nintei@hp-crc.med.osaka-u.ac.jp
Approval Status
Date of approval

Plan to share IPD	Yes
Plan description	This is a multicenter observational study conducted in Japan. Case data will be anonymized and collected using the REDCap system on a server located at Osaka University.

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none