Comparison of Three Approaches of Motor Evoked Potential Recording to Detect a More Reliable Measure to Predict and Prevent Nerve Damage During Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris
研究概览
简要总结
Motor Evoked Potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. This study investigates the utility of three separate quadriceps MEP recording approaches over a total of 40 limbs (20 participants).
详细描述
The long-term objective of this research is to understand how differing recording techniques may enhance the ability to accurately identify clinically relevant changes in Motor Evoked Potentials (MEPs) during a variety of surgeries where the central motor tracts or lumbar spinal roots are at risk.The specific aims of the proposed research are:
- Using transcranial magnetic stimulation, evaluate the effects on compound muscle action potentials utilizing intramuscular bipolar recording vs subdermal referential recordings vs subdermal bipolar recordings.
- Evaluated the variability of amplitude and area between the intramuscular and subdermal recording techniques.
The initial focus will be on recording techniques to obtain stable MEPs in a proximal lower limb muscle, specifically the quadriceps. Continuation research may focus on stimulation techniques to facilitate proximal MEPs and ultimately to improved specificity of MEP changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients must be ≥18 years of age
- •Patients must be undergoing thoracic or lumbar spine surgery where quadriceps MEP recording would be the standard of care
- •Patients should have normal preoperative quadriceps strength
- •Patients are capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed
排除标准
- •Patients with ongoing psychiatric concerns would be excluded.
- •Patients who are non-English speakers.
研究组 & 干预措施
Experimental Arm
Receive Quadriceps MEPs during procedure
干预措施: Quadriceps and Rectus Femoris MEP Recording (Other)
结局指标
主要结局
Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris
时间窗: Duration of surgery
MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.
Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris
时间窗: Duration of surgery
MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.
Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris
时间窗: Duration of surgery
MEPs will be evoked throughout the duration of the surgery. MEPs will be recorded in the Rectus Femoris using intramuscular bipolar electrodes.
次要结局
未报告次要终点