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| Name | Class |
|---|---|
| Beijing Fengtai Hospital | UNKNOWN |
| Peking University First Hospital | OTHER |
| The Chinese University of Hong Kong, Shenzhen | OTHER |
| Beijing Xinzhida Neural Technology Co., Ltd |
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What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative application of high-density flexible μECoG-Guided Resection | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Using High-density Flexible microElectrocorticography for intraoperative monitoring | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure 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. | From surgery to 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From surgery to 1 year postoperatively |
| Postoperative Seizure Outcome According to ILAE Classification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Zhang Dr | Contact | 86 01059975051 | zhangkai62035@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Xingjian Liu, Chao Zhang, Baotian Zhao, et al., Preliminary application study of flexible high-density cortical electrodes in assisting localization of epileptogenic zones during epileptogenic zonectomy, Chinese Journal of Neurosurgery, 2025, 41(12):1237-1244. DOI:10.3760/cma.j.cn112050-20250919-00362 | ||
| 38768406 | Background | Guo J, Wang Z, van 't Klooster MA, Van Der Salm SM, Leijten FS, Braun KP, Zijlmans M. Seizure Outcome After Intraoperative Electrocorticography-Tailored Epilepsy Surgery: A Systematic Review and Meta-Analysis. Neurology. 2024 Jun 11;102(11):e209430. doi: 10.1212/WNL.0000000000209430. Epub 2024 May 20. |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016343 | Monitoring, Intraoperative |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013514 | Surgical Procedures, Operative |
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| UNKNOWN |
| Beijing Neurosurgical Institute | OTHER |
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Outcome assessors will be blinded to group allocation when evaluating postoperative seizure outcomes. Due to the surgical nature of the intervention, participants, care providers, and investigators cannot be masked.
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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. |
| 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. | 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. | Baseline, 6 months postoperatively, and 1 year postoperatively |
| Developmental Function Assessed by the Griffiths Mental Development Scales | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Perioperative period |