NCT00431457已完成不适用
Prospective Randomized Controlled Study of Neurostimulation in the Medial Temporal Lobe for Patients With Medically Refractory Medial Temporal Lobe Epilepsy; Controlled Randomized Stimulation Versus Resection (CoRaStiR)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- To assess whether stimulation produces a reduction in mean monthly seizure frequency that is comparable to resection at 6 and 12 months of follow-up.
研究概览
简要总结
Patients will be prospectively randomized to 3 different treatment arms:
- Treatment group 1: patients who undergo medial temporal lobe resection
- Treatment group 2: patients who receive immediate hippocampal neurostimulation
- Treatment group 3: patients who are implanted with an intracranial electrode but in whom hippocampal neurostimulation is delayed for 6 months.
Twelve months after inclusion unblinding will occur. Patients in group 2 and 3 will have the option to choose between continuing neurostimulation treatment or resective surgery.
Study visits will occur every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presurgical candidates with pharmacoresistant partial seizures despite optimal medical treatment and history of temporal lobe epilepsy
- •Age above 18 years
- •TIQ > 80
- •Able to give informed consent
- •Average of 2 partial seizures per month during a baseline of 3 months. Recording of seizures must have been done in a prospective manner using standard seizure diaries.
- •Able to adequately report seizure frequencies using standard seizure diaries
- •Video-EEG characteristics showing temporal lobe seizure onset (left-sided or right-sided seizure onset) in at least one recorded habitual seizure
- •Presence of a structural abnormality in the medial temporal lobe, suggestive of hippocampal sclerosis as evidenced by optimum MRI
- •Women of child-bearing age will be required to use a reliable method of contraception during the study duration
排除标准
- •Extratemporal epilepsy; multifocal epilepsy; evidence of bilateral medial temporal lobe epilepsy
- •MR evidence of potentially epileptogenic lesions outside the medial temporal lobe such as dysplasias, tumours or cavernomas
- •Prior resective intracranial surgery
- •Patients who are candidates for invasive video-EEG recording or have previously been investigated with invasive video-EEG recording
- •Patients who previously underwent any other type of neurostimulation for treating epilepsy
- •Patients who are unable to fill in questionnaires and comply with protocol requirements
- •Progressive neurological or medical conditions
- •Medical or psychiatric conditions precluding surgery or compliance
- •Patients taking antidepressant medication
- •Pregnancy at study onset
- •Previous (within the last 3 months), ongoing or planned participation in other treatment study protocols for epilepsy
- •Contraindication for intracranial surgery
研究组 & 干预措施
Implantation intracranial electrode with immediate stimulation
Active Comparator
干预措施: Implantation of an intracranial electrode (Device)
Implantation intracranial electrode without stimulation
Placebo Comparator
干预措施: Implantation of an intracranial electrode (Device)
Resective surgery: amygddohyppocampertomy
Active Comparator
干预措施: amygddohyppocampertomy (Procedure)
结局指标
主要结局
To assess whether stimulation produces a reduction in mean monthly seizure frequency that is comparable to resection at 6 and 12 months of follow-up.
时间窗: at 6 and 12 months of follow-up
To assess whether stimulation and/or resection produces a reduction in mean monthly seizure frequency that is greater than in the control group over 6 months of follow-up.
时间窗: 6 months
次要结局
- To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up.(at 12 months of follow-up)
- mean seizure free interval during 3 month intervals(3 month intervals)
- seizure severity and seizure type during 3-month intervals(3-month intervals)
- quality of life: changes in QOLIE 89 score at 6 and 12 months(at 6 and 12 months)
- responder rates during 3 month intervals(3 months intervals)
- Operative and postoperative complications and long-term side effects(during twelve months after inclusion)
- Safety Objectives:(during twelve months after inclusion)
- mood assessment: changes in Beck depression scale scores at 6 and 12 month(at 6 and 12 month)
研究者
研究点 (3)
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