State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Gait: Step Time
研究概览
简要总结
Primary objectives.
The ability of the RC+S to record Local Field Potentials (LFP's) is novel in Deep Brain Stimulation (DBS) technology. The primary goals of this project are to use this function of the RC+S to characterize:
- The state- and target-dependency of neuronal oscillations in the subthalamic nucleus (STN), internal globus pallidus (GPi) or external globus pallidus (GPe) of patients with PD,
- How these oscillations are altered by levodopa,
- The effects of unilateral standard clinical isochronal (e.g. 140 Hz) GPi-, GPe-, and STN-DBS on oscillatory activity and its relationship to the presence and severity of parkinsonian motor signs.
These experiments will leverage the capacity to record LFPs from macroelectrodes implanted in either the GPi/GPe or STN using the Medtronic RC+S DBS system. The long-term goal for this project is to develop closed-loop methods for DBS that are state (resting vs. movement) and movement-phase appropriate.
Secondary objectives.
In addition to establishing the relationship between neural oscillations in the STN, GPi and GPe to clinical and quantitative measures of akinesia, bradykinesia, tremor and rigidity, this project will also examine the relationship of neural oscillations to:
- Levodopa-resistant motor features such as postural instability and gait (including freezing of gait),
- Response inhibition and impulse control.
详细描述
The Olympus Research System (RC+S) is an implantable pulse generator (IPG) designed to deliver deep brain stimulation (DBS) like a standard clinical neurostimulator, but which allows recordings of local field potential (LFP) activity from the implanted DBS lead.
LFPs are composite electrical signals generated by the brain. They are conventionally divided into frequency bands, as follows: 0-3 Hz (delta), 4-7 Hz (theta), 8-12 Hz (alpha), 13-30 Hz (beta), 31-200 Hz (gamma), and >200 Hz (high frequency). The instantaneous amplitude and power of the LFP recordings are believed to represent the degree of synchronization among neurons surrounding the electrode. A transient increase in power in a particular band, in response to a behavioral event, is called an event-related synchronization (ERS), while a transient decrease in power is called event-related desynchronization (ERD). ERD and ERS are typically calculated by averaging the power across time segments and comparing this average to a reference epoch.
Research staff at the University of Minnesota will follow FDA guidelines for software development for the RC+S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 PD.
- •Age 45-75 years
- •Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
- •Clinical plan for unilateral STN- or GPi-DBS surgery to treat their clinical motor signs within the next four months
- •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., major 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 MR imaging (e.g., due to incompatible implanted pacemaker)
- •Previous pallidotomy or DBS surgery
- •Women who are currently pregnant
- •MRI brain abnormalities that could indicate a neurological disorder other than idiopathic Lewy body Parkinson's disease.
- •Subjects with severe or poorly controlled depression defined according to DSM-V criteria and a scored on a validated depression assessment scale.
- •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.
研究组 & 干预措施
Device Implantation
Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system
干预措施: Medtronic RC+S DBS system (Device)
结局指标
主要结局
Gait: Step Time
时间窗: 6-months
Step time
Gait: Step length
时间窗: 6-months
Step length
Gait: Double Support Time
时间窗: 6-months
Double support time
Gait: Obstacles
时间窗: 6-months
Percentage of obstacles successfully avoided
Gait: Freezing Episodes Duration
时间窗: 6-months
Duration of freezing episodes
Gait: Freezing Episodes Number
时间窗: 6-months
Number of freezing episodes
Passive and Active Rigidity Quantification
时间窗: 6-months
Peak resistive torque integral of resistive torque over the pronation and supination Range of Motion (ROM)
Ballistic Elbow Flexion to a Target: Peak Velocity
时间窗: 6-months
Peak velocity
Ballistic Elbow Flexion to a Target: Stop Reaction Time
时间窗: 6-months
Stop reaction time
Rapid Alternating Pronation-Supination Movements: RMS
时间窗: 6-months
Root Mean Square (RMS)-Displacement RMS
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Duration
时间窗: 6-months
Duration of hesitation or arrest (freezing) episodes
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Number
时间窗: 6-months
Number of hesitation or arrest (freezing) episodes
次要结局
未报告次要终点