背景:闭环脊髓刺激(CL-SCS)是最近推出的一种系统,该系统记录了每个刺激脉冲引起的脊髓诱发的复合动作电位(ECAP),并使用此信息自动调整实时刺激强度,称为ECAP控制的SCS。这种创新的系统通过将神经反应(ECAP)保持在预定的目标水平来补偿硬膜外导联和脊髓之间距离的波动。此数据收集研究旨在评估在多个欧洲中心的正常使用条件下,第一个CL-SCS系统在实际环境中的性能。该研究分析并呈现临床结果以及电生理和设备数据,并将这些发现与较早的同一系统上市前研究报告的结果进行比较。
方法:这种前瞻性,多中心,观察性研究在13个欧洲中心进行,旨在收集电生理和设备数据.该研究的重点是该系统在治疗影响躯干和/或四肢的慢性疼痛中的实际应用。遵守标准的使用条件。除了收集和分析基本的人口统计信息,该研究提供了在多个欧洲中心永久植入的首次患者队列的数据.
结果:基线之间的总体背部或腿部疼痛评分(言语数字评分[VNRS])(平均值±平均值的标准误差[SEM];n=135;8.2±0.1),3个月(n=93;2.3±0.2),6个月(n=82;2.5±0.3),和12个月(n=76;2.5±0.3)。总体疼痛缓解(%)与AVALON和EVOKE研究的比较显示,真实世界数据发布(RWE;71.3%;69.6%)与AVALON(71.2%;73.6%)和EVOKE(78.1%;76.7%)研究在3个月和12个月没有显着差异。进行进一步的调查,以客观地表征SCS治疗的生理参数在该队列中使用的百分比时间超过ECAP阈值(%)的指标,剂量比,和剂量精度(µV),根据先前描述的方法。结果显示,平均90%(40.7-99.2)的刺激高于ECAP阈值,剂量比为1.3(1.1-1.4),剂量精度为4.4µV(0.0-7.1),基于236、230和254名患者的数据,分别。因此,在所有三个指标中,大多数患者的客观治疗指标与先前报道的研究中疼痛缓解的最高水平相对应(超过阈值的使用率>80%,剂量比>1.2,误差<10µV)。
结论:结论:这项研究为ECAP控制的CL-SCS系统的实际应用提供了有价值的见解,强调其维持有效疼痛缓解和客观神经生理学治疗指标的潜力,在随机对照试验中看到的水平,以及通过患者-设备交互指标量化与SCS系统使用相关的患者负担的潜力。
背景:在荷兰,本研究已在国际临床试验注册平台(试验NL7889)上正式注册.在德国,本研究正式注册为NCT05272137,在英国注册为ISCRTN27710516,并已由两国的伦理委员会审查.
BACKGROUND: Closed-loop spinal cord stimulation (CL-SCS) is a recently introduced system that records evoked compound action potentials (ECAPs) from the spinal cord elicited by each stimulation pulse and uses this information to automatically adjust the stimulation strength in real time, known as ECAP-controlled SCS. This innovative system compensates for fluctuations in the distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a predetermined target level. This data collection study was designed to assess the performance of the first CL-SCS system in a real-world setting under normal conditions of use in multiple European centers. The study analyzes and presents clinical outcomes and electrophysiological and device data and compares these findings with those reported in earlier pre-market studies of the same system.
METHODS: This prospective, multicenter, observational study was conducted in 13 European centers and aimed to gather electrophysiological and device data. The study focused on the real-world application of this system in treating chronic pain affecting the trunk and/or limbs, adhering to standard conditions of use. In addition to collecting and analyzing basic demographic information, the study presents data from the inaugural patient cohort permanently implanted at multiple European centers.
RESULTS: A significant decrease in pain intensity was observed for overall back or leg pain scores (verbal numerical rating score [VNRS]) between baseline (mean ± standard error of the mean [SEM]; n = 135; 8.2 ± 0.1), 3 months (n = 93; 2.3 ± 0.2), 6 months (n = 82; 2.5 ± 0.3), and 12 months (n = 76; 2.5 ± 0.3). Comparison of overall pain relief (%) to the AVALON and EVOKE studies showed no significant differences at 3 and 12 months between the real-world data release (RWE; 71.3%; 69.6%) and the AVALON (71.2%; 73.6%) and EVOKE (78.1%; 76.7%) studies. Further investigation was undertaken to objectively characterize the physiological parameters of SCS therapy in this cohort using the metrics of percent time above ECAP threshold (%), dose ratio, and dose accuracy (µV), according to previously described methods. Results showed that a median of 90% (40.7-99.2) of stimuli were above the ECAP threshold, with a dose ratio of 1.3 (1.1-1.4) and dose accuracy of 4.4 µV (0.0-7.1), based on data from 236, 230, and 254 patients, respectively. Thus, across all three metrics, the majority of patients had objective therapy metrics corresponding to the highest levels of pain relief in previously reported studies (usage over threshold > 80%, dose ratio > 1.2, and error < 10 µV).
CONCLUSIONS: In conclusion, this study provides valuable insights into the real-world application of the ECAP-controlled CL-SCS system, highlighting its potential for maintaining effective pain relief and objective neurophysiological therapy metrics at levels seen in randomized control trials, and potential for quantifying patient burden associated with SCS system use via patient-device interaction metrics.
BACKGROUND: In the Netherlands, the study is duly registered on the International Clinical Trials Registry Platform (Trial NL7889). In Germany, the study is duly registered as NCT05272137 and in the United Kingdom as ISCRTN27710516 and has been reviewed by the ethics committee in both countries.