Pulvinar Stimulation in Epilepsy: a Pilot Study
概览
- 阶段
- 不适用
- 干预措施
- Pulvinar deep brain stimulation
- 疾病 / 适应症
- Epilepsy
- 发起方
- Assistance Publique Hopitaux De Marseille
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of seizures
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
Deep brain stimulation (DBS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated, and vagal nerve stimulation (VNS) demonstrated no efficacy. Benefits such as reduction of seizure frequency have been shown for thalamic stimulation of the anterior thalamic nucleus (ANT), however it has limited efficacy and non-optimal neurocognitive outcome, making the search for other targets crucial in this context. We propose a novel target for DBS stimulation in drug-resistant epilepsy namely the medial pulvinar thalamic nucleus (PuM).
This target has been chosen based on previous retrospective studies demonstrating that PuM is involved during focal seizures and in loss of consciousness and seizure termination. PuM stimulation also showed potential encouraging results based on the feasibility and safetu studies recently published.
The main objective is to obtain a significant percentage of seizure reduction after 12 months of PuM stimulation compared to baseline period. Quality of life and the relationship with psychiatric and cognitive comorbidities will also be assessed.
研究者
入排标准
入选标准
- •Age: between 18 and 60 years old
- •Focal or multifocal drug-resistant epilepsy not operable or failure of epilepsy surgery
- •Vagal nerve stimulation failure (after at least 1 year of treatment or stopped early for worsening seizures)
- •Either patients with epilepsy whose characteristics suggest that it may respond better to stimulation of the pulvinar than the anterior thalamic nucleus stimulation (i.e. posterior quadrant epilepsy, motor/premotor epilepsy, operculo-insular epilepsy, temporal plus epilepsy, lateral temporal epilepsy) or/and patients with previous anterior thalamic nucleus stimulation failure (after 2 years of treatment or stopped early for worsening seizures)
- •Number of seizures \> 4 / month during the baseline (3 months) and before the V0 for at least 3 months
- •Total IQ \> 55
- •Give written consent to the study after receiving clear information
- •Be a beneficiary or affiliated to a health insurance plan
- •For women of childbearing potential, a pregnancy test must be negative before inclusion.
排除标准
- •Difficulty to read or understand the French language, or inability to understand the information regarding the study.
- •Generalized epilepsy
- •Presenting contraindication to MRI, a serious intercurrent pathology, a progressive brain tumor.
- •Pregnancy or breastfeeding
- •Present a history of attempted suicide in the 6 months prior to inclusion or a score ≥ 2 in item 10 of the Montgomery and Asberg Depression Scale (MADRS).
- •Present a surgical or anaesthetic contraindication.
- •Require long-term anticoagulant or platelet aggregation therapy.
- •Hereditary bleeding disorders of coagulation
- •Non obliterated AVM
- •History of Herpes virus brain infection
研究组 & 干预措施
Pulvinar stimulation
Medial pulvinar deep brain stimulation
干预措施: Pulvinar deep brain stimulation
结局指标
主要结局
Number of seizures
时间窗: Change from baseline to 12 months
Events will be recorded using a seizure diary
次要结局
- Score of anxiety(Change from baseline to 12 months)
- Score of depression(Change from baseline to 12 months)
- Score of quality of life(Change from baseline to 12 months)
- Score of epilepsy severity(Change from baseline to 12 months)