Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting
研究概览
简要总结
The study aims to investigate cognitive impairment associated with Deep Brain Stimulation (DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize DBS-related cognitive side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center (Arm 1)
- •Active deep brain stimulation system with implantable pulse generator capable of recording local field potentials (Arm 2)
- •Diagnosis of Parkinson's disease as determined by a movement disorders specialist neurologist
- •Age at least 18
- •Able to participate in intraoperative testing
- •English speaking
排除标准
- •Age less than 18
- •Not able to participate in intraoperative testing (ex unable to comprehend instructions or follow directions)
研究组 & 干预措施
Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment
Neurophysiology recordings will be performed from dorsolateral prefrontal cortex (DLPFC) during deep brain stimulation surgery, with and without STN or GPI stimulation, at rest and during a working memory task.
干预措施: Neural recordings and stimulation (Device)
Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation
Neurophysiology recordings will be performed from subthalamic nucleus (STN) or globus pallidus internus (GPI) with stimulation on and off, at rest and during a working memory task, in patients who have previously been implanted with DBS and have implantable pulse generators capable of recording local field potentials.
干预措施: Neural recordings and stimulation (Device)
结局指标
主要结局
Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting
时间窗: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Working memory tasked will be conducted during surgery, and local field potentials (LFPs) will be recorded from the DLPFC both at rest and during task execution, under two conditions: with and without stimulation.
Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation
时间窗: 1 hour
Local field potentials will be recorded from subthalamic nucleus or globus pallidus internus in patients with an existing DBS system with implantable pulse generator capable of recording local field potentials. Recordings will be performed at rest and during a working memory task, with DBS on and off.
次要结局
未报告次要终点
研究者
Sarah Bick
Assistant Professor of Neurosurgery
Vanderbilt University Medical Center