Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Gait Kinematic Response for 180 and 60Hz DBS
研究概览
简要总结
The objective of this study is to further the understanding and application of 60Hz subthalamic deep brain stimulation (STN-DBS) in Parkinson's patients with gait disorder. The investigators will achieve this through 2 study aims:
- Determine the impact of 60Hz subthalamic deep brain stimulation on gait kinematics using wearable sensors
- Develop machine learning models to predict optimal subthalamic deep brain stimulation frequency based on wearable sensors
详细描述
Gait disorder, which manifests as shuffling, reduction in speed, multistep turning, and/or freezing of gait (FOG), can arise later in the Parkinson's disease (PD) course and cause significant disability. Ultimately, patients are at risk for falls and can become socially isolated due to their mobility limitations. These symptoms tend not to respond to high frequency STN-DBS. However, lower frequency stimulation (60-80Hz) of the STN in treating gait disorder and/or freezing of gait has demonstrated benefit. This study potentially can expand knowledge of 60hz DBS while improving its utilization in combination with PD medications-enabling sustainable and possibly predictable therapeutic benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 21-80
- •Patients diagnosed with Parkinson's disease (PD)
- •PD subjects who have bilateral STN-DBS (greater than 3 months) or in the preoperative stage of being implanted with bilateral STN-DBS
- •Have underlying gait disorder
- •Currently treated with oral levodopa therapy
- •Willingness to comply with all study procedures
排除标准
- •Cognitive deficits based on historical record that limit participant compliance with study protocol
- •Vestibular disorder or musculoskeletal problems affecting gait or balance
研究组 & 干预措施
Deep Brain Stimulation(DBS) OFF Medication
Subthalamic-DBS in the Levodopa OFF state.
干预措施: Deep Brain Stimulation (Device)
Deep Brain Stimulation(DBS) ON Medication
Subthalamic-DBS in the Levodopa ON state.
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
Gait Kinematic Response for 180 and 60Hz DBS
时间窗: 1-2 minute period with each stimulation condition in the Medicated and Unmedicated states.
The measurements of interest were captured during the instrumented walk. Interaction of DBS Frequency and Levodopa on gait kinematics was assessed using LM-ANOVA.
Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML)
时间窗: 2 years
We apply ML techniques to a data set of gait kinematics acquired from instrumented walking assessments and utilize random forest ML algorithms to identify participants' stimulation frequency/medication condition.
次要结局
- Change in Speed of Limb Movements for 180 and 60Hz DBS(1 minute test session for each stimulation condition)
- Change in Hand Tremor Severity for 180 and 60Hz DBS(1 minute test session for each stimulation condition)
研究者
Ritesh Ramdhani, MD
Assistant Professor of Neurology
Northwell Health