Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Average Population Spiking Activity
研究概览
简要总结
The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).
详细描述
In order to find whether dexmedetomidine is optimal for sedation during Deep brain stimulation surgery, we will measure the electrical activity in the STN during Deep brain stimulation surgery, and measure how this activity is changed during administration of Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and pattern in the STN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.
排除标准
- •Hypersensitivity to dexmedetomidine
- •Bradycardia: Sinus rhythm slower than 50 bpm
- •Known or suspected obstructive sleep apnea
- •Suspected difficult intubation
- •Pregnancy
- •Under 18 years of age or over 85 years of age
- •Cognitive disability impairing understanding the experiment or signing the informed consent form
研究组 & 干预措施
Dexmedetomidine during MER
The study is performed in patients undergoing DBS electrode implantation to their STN for the treatment of parkinson's disease. Microelectrode recording (MER) is performed as part of STN electrode implantation surgery, to increase the precision of the stimulating electrode placement. The study includes administration of dexmedetomidine while recording electrical activity at a single location to evaluate the effects of this drug on the MER.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Change in Average Population Spiking Activity
时间窗: 20-35 minutes following drug administration
We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation. For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.
次要结局
- Change in Average Firing Pattern in the STN(20-35 minutes following drug administration)
- Time to Recovery(20-60 minutes after stopping drug administration)
- Portion of Participants With Timely Return of the Neuronal Activity to Baseline(30 minutes after stopping drug administration)