Single-center, Observational Pilot Study on the Use of Intraoperative Neurophysiological Monitoring in Spinal Cord Stimulator Trials
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Spinal Cord Stimulator (SCS) Coverage
研究概览
简要总结
This is an observational pilot study. The spinal cord stimulator (SCS) procedure and neuromonitoring device is not under investigation. Neuromonitoring is typically performed on this patient population receiving SCS trials here. This study is collecting the data that is transmitted into EPIC from the device that is being collected as part of the patients standard of care. This study will specifically look at Boston Scientific SCS trials as those are the majority of SCS devices that are used here at this medical center
Primary Objective - To evaluate the difference between observed intraoperative neuromonitoring readings and patient reported coverage for spinal cord stimulator trials and
Secondary Objective(s) -
- To evaluate the safety and tolerability of intraoperative neuromonitoring during spinal cord stimulator trials and via documented adverse events and patient elicited feedback on follow up questionnaires.
- Patient satisfaction using PGIC from one week to 6-months post procedure
- Change in pain intensity using NRS from baseline to 6-months post procedure
This study will follow subjects in conjunction with thier standard of care SCS clinic visits. This includes the one week wound check at the pain clinic and then a 2 week end of study phone call.
详细描述
Spinal cord stimulation (SCS) is a neuromodulation procedure that utilizes electrical stimulation via electrodes on the spinal cord for management of various chronic pain states. The most common indications for SCS placement include refractory neuropathic pain, complex regional pain syndromes (CRPS), post-laminectomy/failed back surgery syndrome, and ischemic limb pain related to peripheral vascular disease.1 Upon placing the percutaneous leads in the epidural space, the electrodes or the leads are activated with electrical currents and the patient is asked to report area of paresthesia in response to stimulation.
- Hypothesis This study hypothesizes that one will be able to use percutaneous SCS leads and be able to properly map the dermatomal overlap with the myotomes recorded during the procedure using CMAP.
- Objectives
Primary Objective - To evaluate the difference between observed intraoperative neuromonitoring readings and patient reported coverage for spinal cord stimulator trials and
Secondary Objective(s) -
- To evaluate the safety and tolerability of intraoperative neuromonitoring during spinal cord stimulator trials and via documented adverse events and patient elicited feedback on follow up questionnaires.
- Patient satisfaction using PGIC from one week to 6-months post procedure
- Change in pain intensity using NRS from baseline to 6-months post procedure
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 Lumbar Radiculopathy
- •Expected to receive a Spinal Cord Stimulator trial at at the university of Chicago Medical Center
排除标准
- •Subject is part of a vulnerable population.
- •Cannot consent for themselves
结局指标
主要结局
Spinal Cord Stimulator (SCS) Coverage
时间窗: 2 Weeks
Compare SCS coverage between intraoperative neuromonitoring readings and subject self-report. By testing 18 different muscle groups and then asking the subject to self-report the same muscle groups after they are awake.
次要结局
- Numerical Rating Scale (NRS)(2 Weeks)
- Patient Global Impression of Change (PGIC)(2 Weeks)