Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in impedance value as it relates to the functional state.
研究概览
简要总结
The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in patients of Parkinson disease (PD) as a function of their functional state (lying, sitting and walking) and dopaminergic medication intake (levodopa or dopamine agonists).
The goal is to use DBS measured impedance as a surrogate of the functional and medication states of PD patients.
详细描述
Subjects will be recruited from the population of patients who are already implanted with DBS for treatment of PD.
At the patient's follow up visit they will be asked to come to the clinic in the "off medication" state. Off medication is defined as at least 8 hours since the last medication dosing. Data will be collected during three phases: "OFF" state, transitioning state, and "ON" state. Subjects will be asked to assume different functional states (lying, sitting or walking) for 1 minute each. During these functional states, multiple measures of impedance will be collected.
- "OFF" state data collection: The subject will be examined to assess his motor examination score using the UPDRS-III. Measurements of impedance will be collected multiple times in the lying down and sitting up states.
- Transition state data collection: The subject will be asked to take their dopamine medication. The medication will take approximately 1 hour to take full effect. Measurements of impedance will be collected every 10 minutes during this transition from the "OFF" state to the "ON" state. Patients will be asked to report at what point they felt the "ON: state (they can report the state as "OFF", "unsure", "transition" or "ON").
- "ON" state data collection: The "ON" state examination will start after 1 hour from medication administration. Subjects will be examined using the UPDRS-III. Measurements of impedance will be collected in the lying down, sitting and walking states.
Summary of the study protocol:
"OFF" state Transition state "ON' state UPDRS-III x x Impedance Lying down x x Sitting up x x x Walking x UPDRS I and II x Hoehn and Yahr x x
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's patients with DBS (unilateral or bilateral)
- •Must be taking dopamine agonist or levodopa regimen
- •Medtronic Neurostimulator Activa SC, PC or PC+S (IPG)
排除标准
- •Hoehn and Yahr (H&Y) 4 and above
- •History of DBS revision or lead replacement surgery
- •Current or prior non-Medtronic Activa SC, PC or PC+S IPG
- •Historical information of more than 1 hour delay to "ON" state as average
研究组 & 干预措施
PD patients with implanted DBS
Impedance measurements at different time points.
干预措施: Impedance measurements (Other)
结局指标
主要结局
Change in impedance value as it relates to the functional state.
时间窗: 1 hour (for both outcomes)
Functional state is defined as either: lying, sitting or walking.
Change in impedance value as it relates to the dopaminergic medication state.
时间窗: 1 hour (for both outcomes)
Dopaminergic medications are defined as either levodopa containing or dopamine agonist containing medications. The state is defined as the "OFF" state (medication effect is not present) and "ON" state (medication effect noted).
次要结局
未报告次要终点