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临床试验/NCT00608231
NCT00608231撤回2 期

Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Vanderbilt University1 个研究点 分布在 1 个国家开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

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:

  1. 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.
  2. 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

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

Placebo Comparator

Parkinson's Disease -- GPi target

干预措施: Normal Saline (Drug)

PD-STN

Experimental

Parkinson's Disease -- STN target

干预措施: Dexmedetomidine Hydrochloride Infusion (Drug)

PD - GPi

Experimental

Parkinson's Disease -- GPi target

干预措施: Dexmedetomidine Hydrochloride Infusion (Drug)

ET - VIM

Experimental

Essential Tremor -- VIM target

干预措施: Dexmedetomidine Hydrochloride Infusion (Drug)

Dystonia - GPi

Experimental

Dystonia -- GPi target

干预措施: Dexmedetomidine Hydrochloride Infusion (Drug)

PD - STN Control

Placebo Comparator

Parkinson's Disease -- STN target

干预措施: Normal Saline (Drug)

ET - VIM Control

Placebo Comparator

Essential Tremor -- VIM target

干预措施: Normal Saline (Drug)

Dystonia - GPi Control

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Neimat

Assistant Professor

Vanderbilt University

研究点 (1)

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