Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in frequency band-specific low-frequency power (LFP) with different settings
研究概览
简要总结
Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
A study coordinator who is blinded to the chosen stimulation setting will check the data daily to ensure the patient is wearing the device properly and recording seizure events. At each optimization visit, the MoCA and QOLIE-10P surveys will also be administered to the participants by a member of the research team who is blinded to the group the participant is assigned to.
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
- •medically refractory epilepsy
- •already have a deep brain stimulator in place
排除标准
- •severe dementia at investigator discretion
研究组 & 干预措施
Stimulation Group A
Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS.
干预措施: PS and OS stimulation order 1 (Other)
Stimulation Group B
Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS.
干预措施: PS and OS stimulation order 2 (Other)
Stimulation Group C
Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS.
干预措施: PS and OS stimulation order 3 (Other)
结局指标
主要结局
Difference in frequency band-specific low-frequency power (LFP) with different settings
时间窗: One year from baseline
Different settings include different combinations of stimulation amplitude, frequency and pulse width. The full spectrum PSD data from all of the in-clinic recordings at all of the unique settings will be combined to look at the resulting difference in frequency band-specific LFP.
Difference in broadband power with different settings
时间窗: One year from baseline
Different settings include different combinations of stimulation amplitude, frequency and pulse width. The full spectrum PSD data from all of the in-clinic recordings at all of the unique settings will be combined to look at the resulting difference in broadband power.
次要结局
- Scores on Montreal Cognitive Assessment, MoCA(one year from baseline)
- Identify all seizures(one year from baseline)
- Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P)(One year from baseline)