EASEE® System Pivotal Study for the United States of America
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage reduction in the monthly seizure rate [Effectiveness]
研究概览
简要总结
The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are:
- Is the percentage reduction of monthly seizure rate larger in the Intervention group than in the Control group at the end of the Blinded Phase?
- Is the use of EASEE(R) System safe after up to 28 and up to 84 days?
Participants will be asked to:
- Complete a seizure diary for the duration of the clinical trial
- Attend study visits for 20 months of their clinical trial participation
- Undergo EASEE(R) System implant
- Not be aware if neurostimulation is delivered during the Blinded Phase (6 months)
- Receive neurostimulation for at least 12 months
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult between 18-75 years of age
- •Diagnosis of drug-resistant focal epilepsy
- •At least four (4) observable seizure manifestations per month
- •Stable anti-seizure medication regimen
排除标准
- •Diagnostic of non-epileptic seizures
- •Active idiopathic generalized epilepsy
- •Recent status epileptics (<12 months)
- •Clinically significant or unstable medical condition
- •Active psychosis, major depression, suicidal ideation (<6 months)
- •Pregnancy
- •Implanted with brain stimulation device or active Vagus Nerve Stimulation
研究组 & 干预措施
Intervention group
Participants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not.
干预措施: Implantable minimaly invasive brain stimulator (Device)
Control group
Participants in the Control group have stimulation parameters turned off. Participants do not feel if they are stimulated or not.
干预措施: Implantable minimaly invasive brain stimulator (Device)
结局指标
主要结局
Percentage reduction in the monthly seizure rate [Effectiveness]
时间窗: Baseline and months 5 and 6
Percentage reduction in the monthly seizure rate during months 5 and 6 post-randomization compared to 3 months pre-implant baseline in the Intervention group versus the Control group.
Incidence of Serious Adverse Events [Safety and Tolerability]
时间窗: From implant to days 28 and 84 post-implant
* Acute Serious Adverse Event incidence in the study population * Short term chronic Serious Adverse Event incidence in the study population
次要结局
- Seizure Frequency Responder Rate(from Baseline to 6 months)
- Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome](Baseline to 6 months)
- Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome](Baseline to 6 months)
- Quarterly Seizure Frequency Evaluation(Baseline to 18 months)