Prognostic Value of the 5-SENSE Score to Predict Focality of the Seizure-onset Zone as Assessed by Stereo-electroencephalography - a Prospective Multicenter Validation Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 19
- 主要终点
- Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
研究概览
简要总结
The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 15 years or older in whom no direct surgical approach can be offered and who are discussed in the multidisciplinary team discussion
- •availability of complete non-invasive presurgical work-up (including high-resolution MRI according to the in-center epilepsy protocol, video-telemetry with the recording of a minimum of one habitual clinic and EEG seizure, available as original files for review)
排除标准
- •no telemetry/scalp EEG in center
- •no protocol MRI in center
- •subdural/GRID electrodes
研究组 & 干预措施
Stereoelectroencephalography (SEEG)
Participants undergoing SEEG as part of standard of care.
干预措施: Stereoelectroencephalography (SEEG) (Other)
Control Group
Participants not undergoing SEEG as part of standard of care.
结局指标
主要结局
Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
时间窗: At time of SEEG, up to approximately 1 month
Measured for participants undergoing SEEG
Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG
时间窗: At time of SEEG, up to approximately 1 month
Prospective validation of the predictive value of the 5-SENSE score to identify a focal seizure onset zone (SOZ) in an independent patient sample. Measured for participants undergoing SEEG.
Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG
时间窗: At time of SEEG, up to approximately 1 month
Prospective validation of the predictive value of the 5-SENSE score to identify a focal seizure onset zone (SOZ) in an independent patient sample. Measured for participants undergoing SEEG.
Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
时间窗: At time of SEEG, up to approximately 1 month
Measured for participants undergoing SEEG
次要结局
- Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not(At enrollment)
- Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG(At time of SEEG, up to approximately 1 month)
- Sensitivity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG(At time of SEEG, up to approximately 1 month)