Safety and Efficacy of a Deep Brain Stimulation System in Epilepsy: A Feasibility Study for Tracking Neural Excitability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in Seizure Rate
研究概览
简要总结
The main purpose of this research project is to evaluate the safety and effectiveness of a surgically implanted device called the Medtronic Activa PC+S System in patients with medically refractory epilepsy (people who have seizures that are not completely controlled by medical therapy). The system sends small electrical pulses into a part of the brain called the thalamus to help control seizures. It sends this signal in regularly, regardless of if a seizure is occurring. A different version of this device is already approved for the treatment of epilepsy in Australia. This study aims to use the brain's responses to single pulse electrical stimulation to measure the level of seizure susceptibility. The investigators would like to show that this measure can be used to provide more effective deep brain stimulation therapies, to stop seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Patients with epilepsy with non-resectable pathologies, or clearly defined focal seizures without a defined structural pathology.
- •Patients will be required to have a seizure diary (of up to 3 months) recording at least five seizures per month that are well separated in time (at least 8 hours apart).
排除标准
- •Previous diagnosis of psychogenic/non-epileptic seizures
结局指标
主要结局
Change in Seizure Rate
时间窗: Recorded throughout the baseline (2-4 months post implant) and probe calibrated DBS phase( 6-8 months post implant)
Comparing the number of seizures per patient, as recorded by Medtronic Activa PC+S system in the baseline vs. probe calibrated DBS phase.
次要结局
- Determine if probing responses provide a seizure susceptibility measure.(Throughout probing phase (4-6 months post implant))
- Change in brain excitability following DBS treatment, assessed according to changes in probing response energy before and after stimulation therapy.(Throughout probing phase (4-6 months post implant) and probe calibrated DBS phase (6-8 months post implant).)
研究者
Mark Cook
Principal Investigator
St Vincent's Hospital Melbourne