Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy Associated With Dopaminergic Metabolism Deficit. A Randomized, Double Blind, Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- - Daily seizure frequency at each phase
研究概览
简要总结
The aim of this study is to evaluate the effectiveness and the safety of deep brain stimulation in drug resistant epilepsy.
This is a double blind, controlled and randomized clinical trial with two cross-over groups and four phases.
Phase 1 : base line, open phase consisting of follow-up of patients with their standard treatment.
Phase 2 : Randomisation, lead implantation, followed by 3 months wash out period with the stimulator switch OFF.
Phase 3 : cross-over, double blind phase : 3 months with stimulator switch ON or OFF depending on randomization allocation, followed by 3 months with the stimulator switch on the opposite position. The placebo consisting of turn OFF the stimulator.
Phase 4 : open phase, one year follow-up of all patients with the stimulator switch ON.
详细描述
The experimental work performed for more than 15 years by several research teams shows in animal models of epilepsy, that several circuits of basal ganglia are involved in the control of epilepsy seizures. The existence of those circuits leads to the possibility of therapeutic applications in particular deep brain stimulation.
Preliminary results (Benabid et al, 2002) (Chabardes et al , 2002) suggest that the neuromodulation of basal ganglia and in particular the subthalamic nucleus and the substantia nigra pars reticulata could have a therapeutic effects in patients with drug resistant epilepsy and no possibility of resection surgery.
This is a double blind, controlled and randomized clinical trial with two cross-over groups and four phases.
Phase 1 : base line, open phase consisting of follow-up of patients with their standard treatment.
Phase 2 : Randomisation, lead implantation, followed by 3 months wash out period with the stimulator switch OFF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epilepsy resistant to antiepileptic drug and dopaminergic D2 agonist.
- •No curative exeresis surgery possible
- •Metabolism deficiency of DOPA above 1 DS, evaluated by Positron Emission Tomography (PET) using fluorodopa
- •Age ranging from 18 to 50
- •capacity to consent
- •Affiliation to the French Social Security
排除标准
- •pregnant woman or nursing mother
- •change of antiepileptic, 30 days before base line
- •convulsive "etat de mal" that requires an hospitalisation, 30 days before base line
结局指标
主要结局
- Daily seizure frequency at each phase
时间窗: at each phase
次要结局
- The number of days without seizure during each phase(at each phase)
- Neuropsychological test : WAIS, GROBER and Busckhe, Wisconsin Card Sorting Test, TRAIL test, LURIA test, Beck Depression Inventory, verbal flow test, empathy test(at each phase)
- Quality of life : SEALS, QOLIE-31 and NHP scales(at each phase)