Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 11
- 主要终点
- Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery.
研究概览
简要总结
Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Despite a major medical and socio-economic burden, rationale therapeutic strategies are still under debate. Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases. Precise definition and complete resection of the Epileptogenic Zone are the main determinants of outcome. In current practice of French centers, up to 80% FCD-patients require an intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert opinion.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult or pediatric patient suffering from drug-resistant focal epilepsy;
- •Age more than 2 years old;
- •Brain MRI suggestive of FCD or normal;
- •Standardized presurgical evaluation available including medical history, scalp video-EEG, 3T MRI, FDG-PET, Neuropsychological tests;
- •Inpatient in one of the participating centers for recording seizure during long term scalp video-EEG and / or SEEG-monitoring;
- •Resective surgery with a minimal post-operative follow-up of 12 months;
- •Histopathologic evidence for FCD or non-pathologic findings (normal histology or mMCD type II).
- •Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures.
排除标准
- •Brain MRI suggestive of another type of lesion;
- •Difficulty to read or understand French, or inability to understand the information;
- •Pregnant or breastfeeding woman;
- •Subject under judicial protection.
- •Other lesion discovered on histological examination;
- •FCD type 3, dual pathology, ambiguous or unavailable neuropathological findings
- •Lack of longitudinal pre- and post-surgical follow-up.
结局指标
主要结局
Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery.
时间窗: 12 month
次要结局
- Proportion of each of six seizure-onset pattern types within each of three histologically defined subgroups (FCD type I, FCD type II, non-pathologic findings).(12 month)
- Duration of epilepsy before surgery in patients with focal and network epileptogenic zone (defined by EI)(12 month)
- Topographic distribution of structures that disclose high Epileptogenicity Index values (EI>0.4), of structures with maximal interictal HFO rates and of structures showing interictal/preictal functional connectivity alterations(12 month)