Evaluation of Transcutaneous Stimulation of Lumbosacral Nerve Roots: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.
研究概览
简要总结
Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been demonstrated, it is hypothesized that more information may be gathered if a greater section of the motor neural pathway was monitored (i.e., stimulation above the surgical site and recording the subsequent muscle response in the lower limbs). Currently, there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots locally, but well-above the surgical site in this fashion.
This protocol is intended to evaluate the feasibility and reproducibility of using surface stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and record responses from the relevant innervated muscle groups of the lower limbs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male and female spine surgery patients who are at least 18 years of age
- •Surgical candidates for lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5
- •Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation
排除标准
- •Currently undergoing surgical treatment at any spinal level other than L2 to L5, including S1
- •Pregnant women
- •Implanted pacemaker, defibrillator, or other electronic devices
- •Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- •Underlying neurological disease or neurological deficit that is not associated with the condition for which he/she is seeking surgical intervention (e.g., diabetic peripheral neuropathy)
结局指标
主要结局
Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.
时间窗: Intraoperative
次要结局
- Correlation of any observed changes in the response or response thresholds with surgical events.(Intraoperative)
- Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.(Intraoperative)
- Correlation between observed changes in the response or response threshold and postoperative neural status.(6 weeks postoperative)