UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Acronym	Retrospective exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Scientific Title	Retrospective exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Scientific Title:Acronym	Retrospective exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Region	Japan

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

Objectives
Narrative objectives1	In this study, we analyze the effect of anesthetic agents on electroencephalography in refractory epilepsy patients equipped with chronic intracranial electrode. Our aim of this study is to examine whether it is possible to identify the epileptogenic foci of the patient using this method. Finally, it is expected that refractory epilepsy patients undergoing focal lobectomy can skip intracranial electrode placement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MI value at each anesthesia stage and each intracranial electrode. The ECoG analysis period was divided into the following five anesthetic stages: [1] baseline wakefulness before the anesthetic induction; [2] first 1/3; [3] middle 1/3; [4] last 1/3 periods between the sevoflurane initiation and its concentration reaching 2.0 MAC; [5] sevoflurane 2.0 MAC maintenance.
Key secondary outcomes	MI value at given anesthesia stage and given intracranial electrode when the epileptigenic region and the non-epileptic region are classified

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with refractory epilepsy who are scheduled for focal resection after placement of intracranial electrode 2) Patients with obvious abnormalities in MRI in the area expected to show epileptogenicity 3) Patients with ASA-PS (American association of anesthesia physical status) 1-2 4) Patients in NCNP hospital 5) Patients achieving ILAE class 1 outcome at least six months after surgical resection
Key exclusion criteria	1) Patients who cannot be used sevoflurane 2) Patients who cannot be used propofol 3) The case an anesthetic other than sevoflurane, propofol, remifentanil, rocuronium is used during EEG measurement 4) Patients with ASA-PS3 or higher 5) Patients with epilepsy surgery not intended for radical surgery 6) The case does not agree with the prescribed bank consent 7) Other persons whom representative of this study consider inappropriate 8) Patients achieving ILAE class 2 or higher outcome at least six months after surgical resection
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Keiko Middle name Last name Wada
Organization	National Center of Neurology and Psychiatry
Division name	Department of Anesthesiology
Zip code	187-8551
Address	4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
TEL	042-341-2712
Email	keikotoki@ncnp.go.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Wada
Organization	National Center of Neurology and Psychiatry
Division name	Department of Anesthesiology
Zip code	187-8551
Address	4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
TEL	042-341-2712
Homepage URL
Email	keikotoki@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center of Neurology and Psychiatry
Address	4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
Tel	042-341-2712
Email	rinri-jimu@ncnp.go.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 07 Month 13 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	8
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	Completed
Date of protocol fixation	2021 Year 04 Month 20 Day
Date of IRB	2021 Year 06 Month 30 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2021 Year 11 Month 04 Day
Date of closure to data entry	2021 Year 11 Month 04 Day
Date trial data considered complete	2021 Year 11 Month 04 Day
Date analysis concluded	2021 Year 11 Month 04 Day

Other
Other related information	observational study

Management information
Registered date	2021 Year 07 Month 13 Day
Last modified on	2022 Year 01 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051221