Long term prospective correlative cohort study on outcomes from epilepsy surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- seizure outcome
研究概览
简要总结
This prospective cohort study will be conducted at the Department of Department of Amrita Advanced centre for Epilepsy (AACE). It will include all pharmaco-resistant epilepsy patients who will undergo refractive surgery as determined by the pre-surgical epilepsy conference. Data will be collected after obtaining the informed consed form. Data collected will encompass demographic and clinical information obtained directly from patient interviews, as well as electrophysiological, imaging, and post-processing data acquired from the PEC meeting. This data will be recorded directly in the EDC system. The entered data will be verified and validated by the PI or the PI’s designee according to the data management plan. The cleaned data will then be statistically analyzed and utilized for publications in future.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢All patients with pharmaco-resistant epilepsy who undergo epilepsy surgery as determined by the multidisciplinary pre-surgical epilepsy patient management conference ( PMC).
- •â€¢ Patients who are interested to participate in the study.
排除标准
- •Patients who are already controlled with anticonvulsant drug treatment.
- •â€¢ Participants who are not willing to sign the informed consent document.
结局指标
主要结局
seizure outcome
时间窗: 3 ,6 and 12 months and yearly follow up- up to 5 years
次要结局
- 1. correlation of seizure outcome with individual imaging modalities(2. correlation of seizure outcome with image post-processing analysis)
研究者
Dr Ashok Pillai
Amrita Institute of medical sciences and research centre