Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing a spinal cord stimulation procedure for neuropathic pain
- •must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.
- •subjects must be able to give informed consent.
排除标准
- •patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain
研究组 & 干预措施
Study Group
Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care
干预措施: HD Study Electrode (Device)
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: 3 months
Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.
次要结局
- Pain Catastrophizing Scale (PCS)(3 months)
- McGill Pain Questionnaire (MPQ)(3 month)
- Beck Depression Index (BDI)(3 months)
- Oswestry Disability Index (ODI)(3 months)