Translational Recording and Characterization of Epilepsy Signals Using Subgaleal EEG During Standard-of-care SEEG Monitoring
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Event-Level Seizure Detection by Subgaleal EEG Compared With SEEG
研究概览
简要总结
TRACE is a record-only study evaluating subgaleal EEG (sgEEG) recorded concurrently with standard-of-care stereoelectroencephalography (SEEG) in adults with drug-resistant epilepsy undergoing inpatient epilepsy monitoring. The study will assess the ability of sgEEG to detect seizures and characterize seizure timing, signal quality and stability, and lateralization compared with SEEG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosis of drug-resistant epilepsy.
- •Scheduled to undergo clinically indicated inpatient standard-of-care stereoelectroencephalography (SEEG) monitoring.
- •Able and willing to provide written informed consent.
- •In the investigator's judgment, able to comply with study procedures.
排除标准
- •Any medical, neurological, psychiatric, or social condition that, in the investigator's judgment, would make participation unsafe or interfere with study procedures or data interpretation.
- •Active infection, skin condition, or other finding at the planned subgaleal electrode placement site that could increase procedural risk.
- •Known bleeding disorder, clinically significant coagulopathy, or use of anticoagulant/antiplatelet therapy that cannot be managed per institutional requirements for the planned procedure.
- •Pregnancy or breastfeeding.
- •Participation in another investigational study that, in the investigator's judgment, could interfere with TRACE procedures or outcomes.
研究组 & 干预措施
Single arm
Record only
干预措施: EEG Record only (Device)
结局指标
主要结局
Event-Level Seizure Detection by Subgaleal EEG Compared With SEEG
时间窗: During concurrent sgEEG and standard-of-care SEEG monitoring, up to 14 days
The proportion of clinically adjudicated SEEG seizures for which a corresponding event is identified on simultaneously recorded subgaleal EEG (sgEEG). SEEG serves as the reference standard.
次要结局
未报告次要终点