Intra-operative Recordings to Characterize Movement Facilitation in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Globus pallidus internus local field potentials
研究概览
简要总结
Several strategies or contexts help patients with Parkinson's disease to move more quickly or normally, however the brain mechanisms underlying these phenomena are poorly understood. The proposed studies use intraoperative recordings during DBS surgery for Parkinson's disease to understand the brain mechanisms supporting improved movements elicited by external cues. The central hypothesis is that distinct networks are involved in movement improvement depending on characteristics of the facilitating stimulus. Participants will perform movement tasks during awake surgery performed exclusively for clinical indications. The identified biomarkers may provide targets for future neuromodulation therapies to improve symptoms that are refractory to current treatments, such as freezing of gait.
详细描述
Patients with Parkinson's disease (PD) will perform computer tasks involving reaching and tapping movements during video recording of movements and electrophysiological recording of brain signals during deep brain stimulation surgery. Experimental manipulations involve different computer stimuli that manipulate the presence or absence of sensory and motivational movement cues. The same experimental manipulations are delivered to all individual subjects. 40 PD patients who are undergoing deep brain stimulation (DBS) surgery for treatment of Parkinson's disease, will perform the tasks during awake surgery and recordings will be obtained from 2 implanted DBS electrodes as well as 2 temporary electrode strips placed on the surface of the brain for research purposes. Study procedures are limited to the intraoperative environment with no additional study visits. All patients will also be asked to perform clinical rating scales and questionnaires and undergo a movement disorders neurological exam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of idiopathic Parkinson's disease based on presence of at least 2 cardinal PD features (tremor, rigidity, or bradykinesia)
- •Undergoing deep brain stimulation surgery for treatment of advanced Parkinson's disease, according to clinical evaluation, including the following criteria:
- •advanced idiopathic PD as determined by OFF unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale > 25
- •L-dopa responsive symptoms with at least 30% improvement in UPDRS III scores on vs. off medication OR medication refractory disabling tremor
- •Persistent disabling motor symptoms or drug side effects (dyskinesias, motor fluctuations, disabling "off" periods) despite optimal medical therapy
- •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
- •medical contraindication to surgery, including use of anticoagulant or antiplatelet therapy within 1 week
- •significant cognitive or psychiatric disease based on clinical neuropsychological testing
结局指标
主要结局
Globus pallidus internus local field potentials
时间窗: baseline
power in the beta band
Frontal and parietal electrocorticography
时间窗: baseline
power in the beta band
次要结局
未报告次要终点
研究者
Kathryn A. Cross, MD, PhD
Assistant Professor in Residence
University of California, Los Angeles