A Prospective Multicenter Case Series Utilizing Intraoperative Neuromonitoring With Evoked Compound Action Potentials to Confirm Spinal Cord Stimulation Lead Placement.

OBJECTIVES: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. MATERIALS AND 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.