Optimal Stimulation Parameters for Spike-ripple Disruption in Patients Undergoing Invasive Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Spike ripple rate
研究概览
简要总结
Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. We compared the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation.
- •Consented for stimulation experiment.
排除标准
- •Baseline spike ripple rate < 0.5/min.
- •Did not complete 3 hours of stimulation.
研究组 & 干预措施
Within subject multi-frequency stimulation
Baseline/no stimulation:
1 Hz stimulation 20 Hz stimulation 40 Hz stimulation 140 Hz stimulation 200 Hz stimulation
干预措施: Neurostimulation (Other)
结局指标
主要结局
Spike ripple rate
时间窗: 1-3 hours
Spike ripple rate (count per minute)
Spike Ripple Rate (Events Per Minute)
时间窗: 3 hours
Spike ripple rate \~ 1 + condition + (1\|subject) This is a within-subject repeated-measures study design analyzed using a generalized linear mixed-effects model. Effect size for each arm (+/- 95% confidence interval) reported below. Treatment response was assessed using the change in spike ripple rate (SR rate) relative to each subject's baseline. For each subject, the treatment response at each stimulation frequency (1 Hz, 20 Hz, 40 Hz, 140 Hz, and 200 Hz) was calculated by subtracting the subject's baseline SR rate from the SR rate measured after stimulation at that frequency. Positive values indicate an increase in SR Rate relative to baseline, whereas negative values indicate a decrease relative to baseline.
次要结局
- Spike rate(1-3 hours)
- Spike Rate (Events Per Minute)(3 hours)
研究者
Catherine Chu, MD
Associate Professor Neurology
Massachusetts General Hospital