NL-OMON22556招募中不适用
Cerebellar stimulation to treat refractory epilepsy in children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Erasmus MC
- 入组人数
- 9
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
入选标准
- •Refractory epilepsy for at least one year, with a seizure frequency of at least four per month.
- •Failure of at least three adequately tried AED regimens, as determined by the principal investigator, including ketogenic diet if appropriate.
- •Age 4 – 18 years at time of inclusion. The first 3 patients are at least 7 years old.
- •Definite diagnosis of epilepsy syndrome as reported by treating clinician according to international standards and confirmed by recruitment team.
- •Written informed consent of parents/caretakers.
排除标准
- •Other progressive neurologic or medical diseases.
- •Evident co-existing non-epileptic seizures.
- •Candidate for resective epilepsy surgery.
- •Inability to complete neuropsychological tests or complete seizure diaries by caretakers.
- •Vagal nerve stimulators in situ.
- •Surgical contraindications such as coagulation disorders.
- •Contraindications for MRI.
- •Anatomical abnormalities of skull and posterior fossa, precluding safe lead placement and fixation.
- •Immune deficiency.
- •Insufficient space or subcutaneous fat to safely implant stimulator.
研究者
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