Motor Network Physiology Characterization During Deep Brain Stimulation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- cortical ECoG and subcortical recordings
研究概览
简要总结
The brain networks controlling movement are complex, involving multiple areas of the brain. Some neurological disorders, like Parkinson's disease (PD) and essential tremor (ET), cause abnormalities in these brain networks. Deep brain stimulation is a treatment that is used to treat these types of neurological diseases and is thought to help patients by modulating brain networks responsible for movement. Levodopa medication is also used to modulate this brain networks in patients with PD. The overall objective is to develop a unified theory of basal ganglia thalamocortical (BGTC) circuit dynamics that accounts for disease symptomatology, movement, and their inter-relationship. The underlying hypothesis, is that the rigidity and bradykinesia of PD are fundamentally related to excessive functional coupling across nodes in the BGTC motor circuit impeding effective information flow. In this research, the investigator will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks to make movement more normal. The investigator will simultaneously assess cortical and subcortical electrophysiology in relation to clinical symptoms and behavioral measures and in response to deep brain stimulation, cortical stimulation, and pharmacologic therapy in patients undergoing Deep Brain Stimulation (DBS) implantation surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease who have been recommended to undergo deep brain stimulation for management of their movement disorder
- •Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
- •Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes
排除标准
- •Patients with recent use (within one week) of anticoagulant or antiplatelet agents
- •Neurocognitive testing indicating amnestic cognitive deficits
研究组 & 干预措施
Parkinson's disease patients
This group consists of Parkinson's disease patients who are undergoing deep brain stimulation surgery for treatment of their movement disorder. Participants will complete behavioral assessments while receiving subcortical DBS stimulation and / or inhaled levodopa medication, Inbrija. Stimulation will be applied at the previously determined therapeutic frequency. Two capsules (84 mg) of Inbrija will be administered.
干预措施: Apomorphine Injectable Solution (Drug)
Parkinson's disease patients
This group consists of Parkinson's disease patients who are undergoing deep brain stimulation surgery for treatment of their movement disorder. Participants will complete behavioral assessments while receiving subcortical DBS stimulation and / or inhaled levodopa medication, Inbrija. Stimulation will be applied at the previously determined therapeutic frequency. Two capsules (84 mg) of Inbrija will be administered.
干预措施: Subcortical Stimulation (Other)
结局指标
主要结局
cortical ECoG and subcortical recordings
时间窗: baseline
Cortical ECoG and subcortical LFP recordings will occur during DBS implantation surgery during the behavioral assessments and/or Inbrija administration.
Behavioral assessment
时间窗: baseline
Each patient will complete a task that assesses the kinematics of movement, self-initiation of movement, and/or effect of Inbrija on movement
次要结局
未报告次要终点
研究者
Nader Pouratian
Professor of Medicine
University of Texas Southwestern Medical Center
