ISRCTN41638605终止未知
Evaluating Dietary Intervention Before surgicaL treatment for Epilepsy (EDIBLE)
niversity College London (UK)0 个研究点目标入组 60 人开始时间: 2014年11月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 60
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
- 性别
- All
入选标准
- •Current as of 19/09/2017:
- •This is applicable to all participating countries with trial approvals working to Protocol V5.0 06/09/2016 except Austria and Germany (working to Protocol V2.0 17/03/2015)
- •1. Children aged 3 - 15 years;
- •2. MRI changes consistent with a diagnosis of FCD type II a or b;
- •3. History of at least two epileptic seizures in the past 6 months before randomisation;
- •4. Seizure semiology consistent with focal onset, agreed after pre-surgical discussion to be surgically treatable;
- •5. Parent/ legal representative willing to give consent.
- •Previous inclusion criteria:
- •1. Children aged 5-15 years
- •2. MRI changes consistent with a diagnosis of Focal Cortical Dysplasia type II a or b
- •3. History of continuing seizures for less than 5 years
- •4. History of at least two epileptic seizures in the past 6 months before randomisation
- •5. Seizure semiology consistent with focal onset, agreed after pre-surgical discussion to be surgically treatable
- •6. Failure of at least two antiepileptic drugs to control the seizures
- •7. Parent/legal representative willing to give consent
排除标准
- •1. Previous use of the ketogenic diet
- •2. Not a surgical candidate for Focal Cortical Dysplasia resection
- •3. Administration of the ketogenic diet is medically contraindicated
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