What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?
1. Compare the effect of intraoperative high-density flexible μECoG guidance versus no intraoperative μECoG guidance on surgical prognosis in patients with drug-resistant focal epilepsy. 2. Explore intraoperative electrophysiological biomarkers recorded by high-density μECoG that are associated with surgical prognosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
During resective epilepsy surgery, a sterile high-density flexible microelectrocorticography will be placed on the exposed cortical surface over the suspected epileptogenic zone and adjacent cortex. The array will be used for high-spatial-resolution intraoperative μECoG recording and real-time analysis of epileptiform activity, including interictal spikes, high-frequency oscillations, spatial discharge gradients, and propagation patterns. The intraoperative ECoG findings will be provided to the surgical team to assist in defining the epileptogenic zone and tailoring the extent of resection. The high-density μECoG is used for intraoperative recording only and will be removed before wound closure.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGSeizure Freedom Rate at 6 Months After Surgery
The proportion of participants who remain free from any type of epileptic seizure during the 6-month postoperative follow-up period.
Time frame: From surgery to 6 months postoperatively
Seizure Freedom Rate at 1 Year After Surgery
The proportion of participants who remain free from any type of epileptic seizure during the 1-year postoperative follow-up period.
Time frame: From surgery to 1 year postoperatively
Postoperative Seizure Outcome According to ILAE Classification
Postoperative seizure outcome will be evaluated using the International League Against Epilepsy classification at 6 months and 1 year after surgery. ILAE class 1 indicates complete seizure freedom without aura, and higher classes indicate worse seizure outcomes.
Time frame: 6 months and 1 year postoperatively
Monthly Seizure Frequency
Monthly seizure frequency will be assessed before surgery and at 6 months and 1 year after surgery. The measure is defined as the average number of epileptic seizures per month.
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Seizure Severity Assessed by the National Hospital Seizure Severity Scale
Seizure severity will be assessed using the National Hospital Seizure Severity Scale (NHS3) before surgery and at 6 months and 1 year after surgery. The NHS3 is a seizure severity scale with scores ranging from 1 to 27, with higher scores indicating more severe seizures and therefore a worse outcome.
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Developmental Function Assessed by the Griffiths Mental Development Scales
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For participants aged 3 to 6 years, developmental function will be evaluated using the Griffiths Mental Development Scales before surgery and at 6 months and 1 year after surgery. The primary reported score will be the General Developmental Quotient or General Quotient. The quotient score ranges from 50 to 150, with higher scores indicating better developmental function and therefore a better outcome.
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive Function Assessed by the Wechsler Intelligence Scale for Children
For participants aged 6 to 16 years, cognitive function will be evaluated using the Wechsler Intelligence Scale for Children before surgery and at 6 months and 1 year after surgery. The primary reported score will be the Full Scale Intelligence Quotient. The Full Scale Intelligence Quotient standard score ranges from 40 to 160, with higher scores indicating better cognitive function and therefore a better outcome.
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive Function Assessed by the Mini-Mental State Examination
For participants older than 16 years, cognitive function will be evaluated using the Mini-Mental State Examination (MMSE) before surgery and at 6 months and 1 year after surgery. The MMSE total score ranges from 0 to 30, with higher scores indicating better cognitive function and therefore a better outcome.
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Quality of Life Assessed by the Quality of Life in Epilepsy Inventory-31 or the Pediatric Quality of Life Inventory Version 4.0
Quality of life will be evaluated before surgery and at 6 months and 1 year after surgery. Adult participants will be assessed using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), and pediatric participants will be assessed using the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0). Both scales are transformed to scores ranging from 0 to 100, with higher scores indicating better quality of life and therefore a better outcome.
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Postoperative Complications
The incidence of postoperative complications, including infection, fever, neurological deficits, and other surgery-related complications, will be recorded during the perioperative period and postoperative follow-up.
Time frame: Perioperative period, 6 months postoperatively, and 1 year postoperatively
Surgery-Related Adverse Events
The incidence of surgery-related adverse events will be recorded during the perioperative period. Adverse events include events directly related to the surgical procedure.
Time frame: Perioperative period
Serious Adverse Events
The incidence of serious adverse events, including postoperative death or severe deterioration of health status during the perioperative period, will be recorded.
Time frame: Perioperative period