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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038697
Receipt No. R000044106
Scientific Title Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Date of disclosure of the study information 2019/12/01
Last modified on 2021/03/29

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Basic information
Public title Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Acronym 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 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 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 Diagnostic accuracy to detect epileptogenic foci using the changing rate of average values of Modulation index before and during anesthetic agents administration (propofol and sevoflurane), referred the foci that is clinically determined by the intracranial electrode as true.
Key secondary outcomes -Diagnostic accuracy to detect epileptogenic foci using the changing rate of maximum values of Modulation index before and during anesthetic agents administration (propofol and sevoflurane) and the absolute values in average and maximum of Modulation index, referred the foci that is clinically determined by the intracranial electrode as true.
-To compare the cases meeting ILAE class 3 or lower during the first 6 months to one year after surgery and cases that does not meet this criteria.
-To examine the relationship between sensitivity and specificity and pathological findings based on individual data.
-To examine the relationship between the average and maximum change rate of Modulation index before and during anesthetic administration or the absolute value of Modulation index during anesthetic administration for each electrode and the ratio of KCC2 to NKCC1 in resected specimens.

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
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
Target sample size 15

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 Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2019 Year 12 Month 01 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 17
Results Primary outcome
1.
Sevoflurane
AUC 0.5863, 95%CI 0.5394-0.6332, P value 0.0003, Specificity when sensitivity is 0.9 0.2371
Propofol
AUC 0.5847, 95%CI 0.5350-0.6343, P value 0.0005,Specificity when sensitivity is 0.9 0.2832
Results date posted
2021 Year 03 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 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
Participant flow We studied patients with intractable epilepsy who underwent intracranial electrode placement followed by resection of epileptic focus from October 2018 to March 2020 and met the following inclusion and exclusion criteria. When the patients were scheduled for surgery, the attending neurosurgeons would contact us. After obtaining written informed consent from the study candidates, we confirmed that the patients met the inclusion criteria and did not meet any of the exclusion criteria. If the study subjects were under the age of 18 or determined to be incapable of obtaining consent, consent was obtained from those who could represent the will and interests of the study subject.
General anesthesia and intracranial EEG recording during general anesthesia
Patients took anticonvulsant as usual on the day of second surgery. No other premedication was used.
After admission to the operating room, we started to perform standard monitoring such as percutaneous oximeter saturation, non-invasive blood pressure measurement, and electrocardiogram on the patient. The intracranial EEG was recorded continuously after the patient entered the operating room.
In our institution, we usually use propofol followed by analgesia and muscle relaxation using remifentanil and rocuronium, and intubate tracheal tube after the start of sevoflurane during induction of anesthesia for epilepsy focus resection.
We performed induction of anesthesia as usual, judging the situation of each patient.
Then, the EEGs recorded before the induction of anesthesia when propofol was injected, and when the expiratory sevoflurane concentration reached 1.5-2.0 minimum alveolar concentration (MAC) were taken as an analysis target.
Adverse events none
Outcome measures Outcomes
1) The primary outcome of this study was diagnostic accuracy to detect epileptogenic foci using the changing rate of average values of MI before and during anesthetic agent administration, referred the foci that is clinically determined by the intracranial electrode as true.
The secondary outcomes of this study were:
2) Diagnostic accuracy to detect epileptogenic foci using the average values of MI, referred the foci that is clinically determined by the intracranial electrode as true.
3) Diagnostic accuracy to detect epileptogenic foci using the changing rate of maximum values of MI before and during anesthetic agent administration, referred the foci that is clinically determined by the intracranial electrode as true.
4) Diagnostic accuracy to detect epileptogenic foci using the maximum values of MI, referred the foci that is clinically determined by the intracranial electrode as true.
5) To compare the cases meeting ILAE class 3 or lower during the first six months to one year after surgery and cases that does not meet this criteria.
6) To examine the relationship between the average and maximum change rate of Modulation index before and during anesthetic administration for each electrode and the ratio of KCC2 to NKCC1 in resected specimens.
7) To examine the relationship between sensitivity and specificity and pathological findings based on individual data.
Plan to share IPD none
IPD sharing Plan description none

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 31 Day
Date of IRB
2018 Year 10 Month 11 Day
Anticipated trial start date
2018 Year 11 Month 13 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 01 Month 17 Day
Date trial data considered complete
2021 Year 02 Month 23 Day
Date analysis concluded
2021 Year 03 Month 10 Day

Other
Other related information observational study

Management information
Registered date
2019 Year 11 Month 27 Day
Last modified on
2021 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044106

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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