NL-OMON51868撤回不适用
Precision Radiation treatment for Epilepsy - PRECISIO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 94
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Age >= 18 years, non-pregnant, written informed consent
- •2. The patient or caretaker is able to keep an epilepsy diary
- •3. The patient has a diagnosis of epilepsy established by a dedicated
- •neurologist
- •4. The patient had at least 3 focal-onset seizures with impairment of
- •consciousness over a 3-month period despite two or more antiepileptic
- •medication trials (according ILAE Task Force on therapeutic strategies)
- •5. Video electroencephalography to determine a well-circumscribed seizure focus
- •6. Imaging evidence (i.e. 3T-MRI) of the anatomic region to be targeted with
- •SRT, correlating with the EZ hypothesis
- •7. A Wada test or a functional MRI to lateralize language has been performed in
- •selected patients
- •8. The patient has completed a standard battery of neuropsychological testing
- •9. The patient been deemed an appropriate candidate for stereotactic
- •radiosurgery by a dedicated Radiation Oncologist and Neurosurgeon and referred
- •for the study by one of the Dutch regional multidisciplinary epilepsy surgery
- •working groups
- •10. Patients that were rejected for surgery in an earlier stage can participate
- •in the trial if the treatment with VNS/DBS was more than 4 years ago.
排除标准
- •1. If a radiation treatment plan with a V12Gy <= 10 cc in healthy brain is not
研究者
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