目的:术中神经监测(IONM)的使用已适应于解决脊髓刺激中的安全性和正确引线定位问题。此多中心案例系列旨在结合使用诱发复合动作电位(ECAP)和延迟反应(LR)记录,并将其与使用IONM获得的结果进行比较。特别是肌电图(EMG),用于确认引线放置。本研究旨在建立ECAP之间的相关性,LR,和EMG,并在与IONM一起使用期间发布ECAP和LR的人类记录。
方法:在两个机构遵循标准神经监测方案,有两个独立的医生和七个病人,作为在ClinicalTrials.gov(NCT02924129)注册的一项更大的正在进行的研究的一部分。进行刺激和记录,顶部和底部,在每个经皮导线上。考虑到ECAP,刺激幅度增加,LR,和EMG阈值。
结果:ECAP,LRs,所有患者均观察到肌电图信号。植入电极上的LR信号和皮下电极上的EMG信号的开始具有很好的相关性(rs=0.94,p<0.001),中位LR:肌电图值为1.06(N=21)。LR:使用配对的Wilcoxon符号秩检验和独立样本Mann-Whitney检验比较了导线顶部(平均值=0.97,N=8)与底部(平均值=1.15,N=13)的EMG。显着差异和统计学差异(分别为p=0.078和p=0.015)。所有位置的平均LR:ECAP>2,总体约3.5。LR:铅的顶部和底部之间的ECAP显着不同(Wilcoxon检验,p<0.01,N=12)。
结论:LR与EMG相关;双侧(不一定对称)EMG活动的导联显示LR:ECAP>1.5。LR:ECAP<1,在ECAP之前生成LR/EMG,表明铅过于横向。ECAP和LR的使用有可能保持客观的铅位置,无需使用IONM进行针头放置。
OBJECTIVE: The use of intraoperative neuromonitoring (IONM) has been adapted to address issues of safety and proper lead positioning in spinal cord stimulation. This multicenter
case series seeks to incorporate the use of evoked compound action potential (ECAP) and late response (LR) recording and compare it with the results obtained with IONM, specifically electromyography (EMG), for the confirmation of lead placement. This study aimed to establish a correlation between ECAPs, LR, and EMG and publish human recordings of ECAPs and LR during their use with IONM.
METHODS: Standard neuromonitoring protocols were followed at two institutions, with two separate physicians and with seven patients, as part of a larger ongoing study registered with ClinicalTrials.gov (NCT02924129). Stimulation and recording were performed, top and bottom, on each percutaneous lead. Stimulation amplitude was increased considering ECAP, LR, and EMG thresholds.
RESULTS: ECAPs, LRs, and EMG signals were observed in all patients. The onset of LR signals on implanted electrodes and EMG signal on subdermal electrodes was well correlated (rs = 0.94, p < 0.001), with a median LR:EMG value of 1.06 (N = 21). LR:EMG for the top (mean = 0.97, N = 8) vs bottom (mean = 1.15, N = 13) of the lead was compared using a paired Wilcoxon signed rank test and an independent samples Mann-Whitney test, revealing a marginally significant and a statistically significant difference (p = 0.078 and p = 0.015, respectively). Mean LR:ECAP was >2 in all locations and approximately 3.5 overall. LR:ECAP between the top and bottom of the lead was significantly different (Wilcoxon test, p < 0.01, N = 12).
CONCLUSIONS: LR correlated with EMG; leads with bilateral (not necessarily symmetric) EMG activity showed LR:ECAP > 1.5. An LR:ECAP of <1, with LR/EMG generated before the ECAP, indicated that the lead is too lateral. The use of ECAP and LR has the potential of maintaining objective lead placement, without the need for needle placement with IONM.