Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Micro-electrode Recordings
研究概览
简要总结
To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings
详细描述
Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders such as Parkinson's disease, essential tremor and dystonia. Because of the uniqueness of each individual brain, the surgery to implant a DBS electrode requires detailed anatomic and physiological information for each patient. The anatomic data is obtained before surgery via a Magnetic Resonance Imaging (MRI) scan of the patient's brain. Physiological data is obtained during the operation via micro-electrode recording of the patient's brain and neurological examination of the patient. Therefore, DBS surgery can be uncomfortable to patients, as it can be very time consuming and requires the patient to be awake and attentive.
The specific aims of this project are:
- To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings.
- To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery have no significant effects on neurological findings and/or patient cooperation during neurological examination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Any patient who has agreed to undergo DBS implantation.
排除标准
- •Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference.
- •Patients not consented for DBS surgery.
- •Patients or legal guardians not able to provide informed consent.
研究组 & 干预措施
PD - GPi Control
Parkinson's Disease -- GPi target
干预措施: Normal Saline (Drug)
PD-STN
Parkinson's Disease -- STN target
干预措施: Dexmedetomidine Hydrochloride Infusion (Drug)
PD - GPi
Parkinson's Disease -- GPi target
干预措施: Dexmedetomidine Hydrochloride Infusion (Drug)
ET - VIM
Essential Tremor -- VIM target
干预措施: Dexmedetomidine Hydrochloride Infusion (Drug)
Dystonia - GPi
Dystonia -- GPi target
干预措施: Dexmedetomidine Hydrochloride Infusion (Drug)
PD - STN Control
Parkinson's Disease -- STN target
干预措施: Normal Saline (Drug)
ET - VIM Control
Essential Tremor -- VIM target
干预措施: Normal Saline (Drug)
Dystonia - GPi Control
Dystonia -- GPi target
干预措施: Normal Saline (Drug)
结局指标
主要结局
Micro-electrode Recordings
时间窗: Intra-operative
次要结局
- Neurological Exam Findings(Intra-operative)
研究者
Joseph Neimat
Assistant Professor
Vanderbilt University