State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Cortical and sub-cortical brain signals using Activa PC+S
研究概览
简要总结
The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in Parkinson's disease and how they relate to DBS and pharmacological management, not to bring new devices to market.
详细描述
Experimental: chronic brain recording This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's Disease (PD).
- •Age 45-75 years
- •UPDRS III motor score (off PD medications) ≥ 25
- •Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
- •Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months
- •Cleared to be scanned in a 7 tesla magnet
- •Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process
排除标准
- •Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)
- •Evidence of secondary or atypical parkinsonism
- •Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
- •Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)
- •Previous pallidotomy or DBS surgery
- •Women who are currently pregnant or are breast feeding
- •MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder
- •Any prior intracranial surgery
- •Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale
- •History of seizures
- •Immunocompromised
- •Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
- •Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
结局指标
主要结局
Cortical and sub-cortical brain signals using Activa PC+S
时间窗: 12 months
Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.
次要结局
未报告次要终点