Mechanisms and Effects of Pallidal Deep Brain Stimulation on Levodopa Resistant Motor Signs in Parkinson's Disease; Udall Project 2 Aim 2A&C
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Stride length
研究概览
简要总结
This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC or RC DBS system to study the effects of globus pallidus internus, globus pallidus externus (GPi, GPe), and subthalamic nucleus (STN) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over a minimum of 4 weeks). These experiments will elucidate the relationships between LFPs oscillations, lower limb function, postural control and gait performance.
详细描述
This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC or RC DBS system to study the effects of globus pallidus internus, globus pallidus externus (GPi, GPe), and subthalamic nucleus (STN) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over a minimum of 4 weeks). These experiments will elucidate the relationships between LFPs oscillations, lower limb function, postural control and gait performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving DBS therapy in GP for treatment of PD
- •Implanted with Medtronic Percept DBS system
- •At least 3 months since initial activation of the neurostimulator
- •For the "At Home" experiment only: participants with DBS settings that are sensing compatible.
排除标准
- •history of musculoskeletal disorders that significantly affects the ability to perform the motor tasks in the specific experiment in question
- •history of dementia or cognitive impairment
- •other significant neurological disorder as determined by the PI
- •post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment
- •lack of capacity to consent (as identified by MaCAT-CR)
研究组 & 干预措施
Participants
Inclusion criteria for all aims/experiments
- Receiving DBS therapy in GP or STN for treatment of PD
- Implanted with Medtronic Percept DBS system
- At least 3 months since initial activation of the neurostimulator
干预措施: observational-- no intervention (Other)
结局指标
主要结局
Stride length
时间窗: 30 days
The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)
Peak negative power
时间窗: 30 day
A servo-controlled ankle manipulandum will be used to obtain objective measures of resistance about the dorsiflexion/plantar flexion axis (range of motion approximately 5 deg. dorsiflexion to 30 deg. plantar flexion; frequency = 1.5 Hz). Two conditions will be tested: passive movement with and without an activation maneuver on the contralateral side (repetitive tapping of the toe or heel).
Alpha power during standardized daily gait assessment
时间窗: 30 days
The participant will use their DBS device patient programmer to record a time stamp and capture LFPs using the implanted Medtronic Percept™ device during the standardized daily gait assessments.
cadence
时间窗: 30 days
The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)
次要结局
- time spent away from home(30 days)
- step length variability(30 days)
- alpha power immediately following freezing of gait episodes, falls and other major events(30 days)
- stride time variability(30 days)
- gait speed(30 days)
- distance traveled from home(30 days)
- Peak power of local field potential oscillations(30 days)