NCT07656857招募中不适用
Precision Resection of the Epileptogenic Zone Using Intraoperative Submillimeter Micro-Electrocorticography (Epi-PRECISE): A Single-Arm Trial With an External Historical Control Cohort
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Seizure Freedom Rate at 6 Months After Surgery
研究概览
简要总结
What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?
详细描述
- 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.
- Explore intraoperative electrophysiological biomarkers recorded by high-density μECoG that are associated with surgical prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3 to 60 years.
- •Diagnosis of drug-resistant epilepsy, defined as persistent seizures despite treatment with two or more appropriately selected, adequately dosed and adequately tried antiseizure medications.
- •Diagnosis of focal epilepsy after standard presurgical evaluation and considered suitable for resective epilepsy surgery.
- •Preoperative cognitive or developmental status sufficient to participate in study assessments, as judged by the investigator and assessed using age-appropriate validated instruments. For participants aged 3 to 6 years, developmental status must be within the normal range according to the Griffiths Mental Development Scales. For participants aged 6 to 16 years, cognitive function must be within the normal range according to the Wechsler Intelligence Scale for Children. For participants older than 16 years, a Mini-Mental State Examination score of 24 or higher will be required.
- •Written informed consent provided by the participant or, when applicable, by a legal guardian.
排除标准
- •Suspected mesial temporal lobe epilepsy after multidisciplinary presurgical evaluation.
- •History of any previous neurosurgical craniotomy before epilepsy surgery.
- •Severe psychiatric, cognitive, or psychological disorder that prevents participation in the study or completion of follow-up.
- •Contraindication to surgery.
研究组 & 干预措施
Intraoperative application of high-density flexible μECoG-Guided Resection
Experimental
干预措施: Using High-density Flexible microElectrocorticography for intraoperative monitoring (Device)
结局指标
主要结局
Seizure Freedom Rate at 6 Months After Surgery
时间窗: From surgery to 6 months postoperatively
The proportion of participants who remain free from any type of epileptic seizure during the 6-month postoperative follow-up period.
次要结局
- Seizure Severity Assessed by the National Hospital Seizure Severity Scale(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Developmental Function Assessed by the Griffiths Mental Development Scales(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Cognitive Function Assessed by the Wechsler Intelligence Scale for Children(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Cognitive Function Assessed by the Mini-Mental State Examination(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(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Seizure Freedom Rate at 1 Year After Surgery(From surgery to 1 year postoperatively)
- Postoperative Seizure Outcome According to ILAE Classification(6 months and 1 year postoperatively)
- Monthly Seizure Frequency(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Postoperative Complications(Perioperative period, 6 months postoperatively, and 1 year postoperatively)
- Surgery-Related Adverse Events(Perioperative period)
- Serious Adverse Events(Perioperative period)
研究者
Kai Zhang
Director of the Department of Neurosurgery, Clinical Professor
Beijing Neurosurgical Institute
研究点 (1)
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