Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)

Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study) - Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038697

Enrollment

Registered

2019-12-01

Start date

2018-11-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory epilepsy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
-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.	—

Measure

Time frame

-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.

—

Countries

Japan

Contacts

Public ContactKeiko Wada

National Center of Neurology and Psychiatry Department of Anesthesiology

keikotoki@ncnp.go.jp042-341-2712

Outcome results