Clinical and Medico-economical Assessment of Deep Brain Stimulation of the Anterior Nucleus of the Thalamus for the Treatment of Pharmacoresistant Partial Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 11
- 主要终点
- Assessment of effectiveness of thalamic DBS on seizures severity
研究概览
简要总结
The main objective of the study is twofold:
- Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up.
- Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years.
The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe crises) of the most severe seizures, in at least 50% of patients who have drug-resistant partial epilepsy; and should also improve significantly the quality of life through a gain of independence in activities of daily life, the possible recovery of functional abilities, recovery of social or professional activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with focal or multifocal epilepsy with or without secondary generalized seizure inoperable at the time of inclusion
- •Failure of pharmacological therapies (pharmacoresistant epilepsy) for over 4 years (persistent seizures despite at least two anti-epileptic treatments used at the optimal dose for at least 2 years)
- •Failure of vagus nerve stimulation, defined as the persistence of crises considered debilitating after 2 years of VNS's treatment
- •VNS failure in a patient treated with VNS, for less than 2 years. with stop early due to the worsening crisis
- •Intelligence quotient above 55
- •Have the written consent of the legal representative for patients under guardianship and minors
- •Affiliation to the french social security system or equivalent
- •People who signed the consent form
- •Seizure frequency at least 4 crisis / month on average for at least 3 months, about 12 crisis in 3 months objectified by the neurologist during visit pre-inclusion, and confirmed by the neurologist after 3 months of Baseline during the inclusion visit
排除标准
- •Patient with a generalized epilepsy Immediately
- •Patient with a simple partial seizures (subjective manifestations only)
- •Patient with a cons-indication for MRI, a serious intercurrent disease, a progressive brain tumor
- •Patient with a suicide risk of in the six months preceding the inclusion visit (score ≥ 2 on item 10 of the Montgomery-Asberg Depression Rating Scale)
- •Patient a surgical or anesthetic cons-indication
- •Patient with anticoagulant or antiplatelet treatment in the long term
- •Woman of childbearing potential without effective contraception, or pregnant or lactating
- •People hospitalized without consent
- •People deprived of freedom
- •Patient currently participating in another clinical research, or who participated in a clinical study in the month preceding the pre-inclusion visit (except for any non-interventional research)
研究组 & 干预措施
AN-DBS
Deep Brain Stimulation of the Anterior Nucleus of the thalamus
干预措施: AN-DBS (Procedure)
Usual treatment
Usual treatment of epilepsy including vagus nerve stimulation (VNS)
干预措施: Usual treatment (Drug)
结局指标
主要结局
Assessment of effectiveness of thalamic DBS on seizures severity
时间窗: 2 years
The main objective of the study is twofold : to assess the effectiveness of DBS on seizures according to their severity at 1 year follow up and to perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years.
次要结局
- Comparison of the improvement of quality of life and overall neuropsychological impact(2 years)
- Comparison the adverse effects (including depression)(2 years)
- Impact of th new therapeutic strategy on the hospital budget(2 years)
- Cost-utility analysis from the perspective of Medicare(2 years)