Prospective Multicenter Study on Localization Accuracy and Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation( PROMAESIS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- the clinical utility of ESI in management of the patient with medically refractory epilepsy
研究概览
简要总结
Electrical source imaging is part of the presurgical evaluation of patients with drug-resistant focal epilepsy. The software packages that will be used in this study have Declaration of Conformity within the European Economic Area (CE mark) for this specific medical use. In spite of being part of the clinical standard, the evidence for the accuracy and clinical utility of these methods are derived from several smaller-scale and retrospective studies. The PROMAESIS study will provide solid evidence of the accuracy and clinical utility of automated ESI.
详细描述
One-third of patients with epilepsy have seizures resistant to pharmacotherapy. There are many approaches developed to control these seizures, yet epilepsy surgery is still the most common method. The crucial part of epilepsy surgery is to assess the epileptic zone in order to render patients seizure free. However, accurate localization of the epileptic zone is often challenging due to the multimodal approach. This contains semiology, EEG (obtained during long term video-EEG monitoring), magnetic resonance Imaging (MRI), in addition to certain cases, positron emission computed tomography (PET), and single photon emission computed tomography (SPECT) and magnetoencephalography (MEG). At present, in one of the third patients, seizure remains after epilepsy surgery. Therefore a new preoperative method should be improved to assess the epileptic zone. Automated ESI is a post-processing novel method that estimates the location in the brain of the source of the recorded EEG signals.
The objective of this study is:
- To determine the accuracy of ESI in localizing the epileptic focus.
- To determine the clinical utility of ESI on clinical decision making
Methods:
Study design: a prospective diagnostic study in line with the Standards for Reporting Diagnostic Accuracy Studies (STARD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with drug resistant focal epilepsy, admitted to Epilepsy Monitoring Unit for presurgical evaluation, who are afterwards discussed at the multidisciplinary epilepsy surgery team meetings.
排除标准
- •Patients who did not have a seizure during the monitoring.
结局指标
主要结局
the clinical utility of ESI in management of the patient with medically refractory epilepsy
时间窗: 2 years
For determining the clinical utility, the percentage of patients in whom automated ESI change decision on patients management will be calculated.
The Sensitivity and Specificity of automated ESI in presurgical evaluation.
时间窗: 2 Years
For determining the the accuracy (sensitivity and specificity) of automated ESI, one year outcome after the operation will be calculated based on the defined criteria. * True Positive (TP): source is in the same sub-lobar region as the resection, seizure-free outcome * False Positive (FP): source is in the same sub-lobar region as the resection, not seizure-free outcome * True Negative (TN): source outside the sub-lobar region that was resected, not seizure-free outcome * False Negative (FN): source outside the sub-lobar region that was resected, seizure-free outcome.
次要结局
未报告次要终点
研究者
Sándor Beniczky
Professor
Aarhus University Hospital