Bayesian Optimization of DBS for Gait
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Gait Test
研究概览
简要总结
This project aims to establish the feasibility of Bayesian optimization for tuning deep brain stimulation (DBS) to treat gait symptoms in Parkinson's disease (PD) patients. Our primary question is: Can Bayesian optimization of DBS achieve reproducible results within a feasible number of gait measurements? PD patients will be enrolled who have DBS of the subthalamic nucleus (STN) or globus pallidus (GP) in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. We will apply Bayesian optimization to derive DBS settings which maximally lengthen step length relative to the OFF DBS state.
详细描述
Patients will undergo on-label DBS for the treatment of Parkinson's disease, at stimulator settings different from their usual settings, but within the FDA-approved range for this indication, based on the output of the Bayesian optimization algorithm. Test settings will be evaluated by a brief period of walking on a treadmill which captures measurements of step length. The resulting step length will be provided to the algorithm to inform the next recommended test setting. This will be repeated approximately 30 times to reach putatively optimal DBS settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participants will not be told what their DBS stimulation settings are during testing (single blind)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's Disease
- •DBS in STN or GP (bilateral or unilateral)
- •At least 3 months after lead implantation
排除标准
- •Inability to walk in the off-med, off-stimulation condition (even with safety harness)
- •Gait impaired significantly by a condition other than PD, as determined by the PI
- •Breaks or shorts in active contacts
- •IPG battery nearing end of life (in patients with primary-cell IPGs)
- •Females who are nursing or pregnant
- •Diminished capacity to consent (concluded via UBACC)
研究组 & 干预措施
All participants
All participants will be allocated to this group for DBS stimulation within FDA-approved limits and labeling for symptoms of PD.
干预措施: Deep Brain Stimulation (Other)
结局指标
主要结局
Gait Test
时间窗: This will be repeated approximately 30 times throughout the study visit (Day 1) on various DBS settings to reach putatively optimal DBS settings.
Subjects walk for one minute each on a treadmill set to match their individual overground walking speed. A forceplate measures the center of pressure trajectory from which integral software detects time and location of heel-strike and toe-off events. These events, and the treadmill speed, are used to compute step lengths.
次要结局
未报告次要终点