Automated Deep Brain Stimulation Programming Using Functional Mapping
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician
研究概览
简要总结
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The ability to provide informed consent
- •Clinical diagnosis of idiopathic Parkinson's disease (PD)
- •Implanted deep brain stimulation (DBS) system for tremor and/or bradykinesia
排除标准
- •Significant medical or psychiatric illness or dementia as evidenced by a score less than 26 on the Montreal Cognitive Assessment
- •Not capable of functioning independently
- •Individuals so symptomatic as to compromise safety
研究组 & 干预措施
DBS-Expert Programming First
These patients will be undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) first and then be programmed by a clinician within five days.
干预措施: Algorithm based programming using Kinesia-based assessment (Device)
Traditional Programming First
These patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days.
干预措施: Algorithm based programming using Kinesia-based assessment (Device)
结局指标
主要结局
Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician
时间窗: Up to 2 hours (from start of programming session until end of programming session)
Amount of time it took to arrive at DBS settings that provide sufficient therapeutic benefit will be compared across programming sessions
次要结局
未报告次要终点