Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Validate the biological origin of brain signals using an external stimulation/recording system during standard of care Deep Brain Stimulation surgery, both awake and under general anesthesia.
研究概览
简要总结
Our goal is to better understand how DBS modifies local neuronal activity and to pioneer device technologies that can record local DBS-evoked potentials (DLEPs) to guide therapy. Our vision is for a patient's unique electrophysiology to guide both electrode targeting during surgery and programming in clinic, eventually as an integrated component of the implanted pulse generator. Our results will inform directional DBS for PD and serve as a model for translation to other diseases where knowledge on DBS circuit interactions is at an even earlier stage.
详细描述
This study is an exploratory single center double-blind, randomized crossover study of unilateral STN versus GPi versus dual-target STN/GPi DBS for motor symptoms of PD. The dual-target approach will allow unique measures of connectivity between STN and GPi, and within-participant clinical contrasts of single target STN, single target GPi, and combined dual-target stimulation. Longitudinal encounters will measure changes in motor function, non-motor function, and patient reported outcomes versus pre-operative baseline in response to each of these stimulation conditions at 4-month intervals after surgery. These blinded encounters will be followed by an unblinded open-label encounter at 16 months utilizing optimized stimulation parameters. In addition to the clinical crossover design, we will retrospectively investigate the extent to which the spatial maps of local DBS-evoked potentials within and across brain targets predict stimulation sites chosen for clinical therapy at either brain target.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomly assigned each of three different stimulation paradigms for 4 month intervals. Participants and researchers will be blinded to the stimulation paradigm used at any given point in the study.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Validate the biological origin of brain signals using an external stimulation/recording system during standard of care Deep Brain Stimulation surgery, both awake and under general anesthesia.
时间窗: At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia).
The investigator will validate the biological origin of the signals using pairs of DBS pulses and neural refractoriness with an external stimulation/recording system at therapeutically relevant stimulus amplitudes (i.e., inside and outside the therapeutic window).
Test whether directional DBS leads elicit spatiotemporally distinct oscillations in subthalamic nucleus versus globus pallidus interna.
时间窗: At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia).
This investigators efforts will yield granular spatial maps of neural engagement across the two canonical targets for PD to guide targeting (awake or under anesthesia) and clinical programming.
Test whether spatial maps of DBS-evoked oscillations predict clinically effective stimulation sites on a directional DBS lead.
时间窗: At standard of care DBS surgery (awake), approximately one week later at standard of care battery placement (under general anesthesia), at in a research clinical assessment at 16 months after DBS surgery.
The investigator will test whether spatial maps of DBS-evoked neural activity predict clinically effective locations for directional DBS.
次要结局
未报告次要终点
研究者
Harrison Walker, MD
Professor of Neurology
University of Alabama at Birmingham