Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Effect of DBS cessation on motor function over time
研究概览
简要总结
Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. This study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with DBS tuning for the lower extremities and gait in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease
- •Age > 21
- •Underwent DBS surgery targeting the subthalamic nucleus (STN)
- •Bilateral or midline involvement when "off" DBS/medication state
- •Clinical history of gait impairment or freezing of gait
排除标准
- •"Parkinson's plus" syndrome, secondary, or atypical Parkinson's disease
- •Underwent DBS surgery targeting the ventral intermediate (VIM)
- •Unable to walk independent of a wheelchair (use of assistive devices, like a cane, is okay for this study)
- •Dementia (determined by a neuropsychological assessment).
结局指标
主要结局
Effect of DBS cessation on motor function over time
时间窗: All data will be collected within a single session not to exceed 4 hours. All data will be analyzed within one month of study completion.
Motor function evaluations (movement speed and magnitude) will be collected at various time points after DBS cessation. The effects over time will be examined.
次要结局
未报告次要终点