Abstract：
BACKGROUND: Drawbacks of fixed-output spinal cord stimulation (SCS) screening trials may lead to compromised trial outcomes and poor predictability of long-term success. Evoked compound action potential (ECAP) dose-controlled closed-loop (CL) SCS allows objective confirmation of therapeutic neural activation and pulse-to-pulse stimulation adjustment. We report on the immediate patient-reported and neurophysiologic treatment response post-physiologic CL-SCS and feasibility of early SCS trial responder prediction.
METHODS: Patient-reported pain relief, functional improvement, and willingness to proceed to permanent implant were compared between the day of the trial procedure (Day 0) and end of trial (EOT) for 132 participants in the ECAP Study undergoing a trial stimulation period. ECAP-based neurophysiologic measurements from Day 0 and EOT were compared between responder groups.
RESULTS: A high positive predictive value (PPV) was achieved with 98.4% (60/61) of patients successful on the Day 0 evaluation also responding at EOT. The false-positive rate (FPR) was 5.6% (1/18). ECAP-based neurophysiologic measures were not different between patients who passed all Day 0 success criteria (\"Day 0 successes\") and those who did not (\"needed longer to evaluate the therapy\"). However, at EOT, responders had higher therapeutic usage and dose levels compared to non-responders.
CONCLUSIONS: The high PPV and low FPR of the Day 0 evaluation provide confidence in predicting trial outcomes as early as the day of the procedure. Day 0 trials may be beneficial for reducing patient burden and complication rates associated with extended trials. ECAP dose-controlled CL-SCS therapy may provide objective data and rapid-onset pain relief to improve prognostic ability of SCS trials in predicting outcomes.
BACKGROUND: The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).
METHODS: Patient-reported pain relief, functional improvement, and willingness to proceed to permanent implant were compared between the day of the trial procedure (Day 0) and end of trial (EOT) for 132 participants in the ECAP Study undergoing a trial stimulation period. ECAP-based neurophysiologic measurements from Day 0 and EOT were compared between responder groups.
RESULTS: A high positive predictive value (PPV) was achieved with 98.4% (60/61) of patients successful on the Day 0 evaluation also responding at EOT. The false-positive rate (FPR) was 5.6% (1/18). ECAP-based neurophysiologic measures were not different between patients who passed all Day 0 success criteria (\"Day 0 successes\") and those who did not (\"needed longer to evaluate the therapy\"). However, at EOT, responders had higher therapeutic usage and dose levels compared to non-responders.
CONCLUSIONS: The high PPV and low FPR of the Day 0 evaluation provide confidence in predicting trial outcomes as early as the day of the procedure. Day 0 trials may be beneficial for reducing patient burden and complication rates associated with extended trials. ECAP dose-controlled CL-SCS therapy may provide objective data and rapid-onset pain relief to improve prognostic ability of SCS trials in predicting outcomes.
BACKGROUND: The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).
摘要：
背景：固定输出脊髓刺激（SCS）筛查试验的缺陷可能会导致试验结果受损和长期成功的可预测性差。诱发复合动作电位（ECAP）剂量控制闭环（CL）SCS允许客观确认治疗性神经激活和脉冲到脉冲刺激调节。我们报告了患者即时报告和神经生理学治疗后的生理CL-SCS反应以及早期SCS试验应答者预测的可行性。
方法：患者报告疼痛缓解，功能改进，在ECAP研究中,对132名接受试验刺激期的参与者在试验程序当天(第0天)和试验结束(EOT)之间进行永久性植入的意愿进行了比较.在应答者组之间比较从第0天和EOT开始的基于ECAP的神经生理学测量。
结果：实现了高阳性预测值（PPV），其中98.4％（60/61）在第0天评估成功的患者在EOT时也有反应。假阳性率(FPR)为5.6%(1/18)。通过所有第0天成功标准（“第0天成功”）的患者和未通过（“需要更长的时间来评估治疗”）的患者之间基于ECAP的神经生理学措施没有差异。然而,在EOT,与无应答者相比,应答者的治疗使用率和剂量水平更高.
结论：第0天的高PPV和低FPR评估为早在手术当天预测试验结果提供了信心。第0天的试验可能有利于减少与延长试验相关的患者负担和并发症发生率。ECAP剂量控制CL-SCS治疗可提供客观数据和快速缓解疼痛，以提高SCS试验预测预后的能力。
背景：ECAP研究已在ClinicalTrials.gov（NCT04319887）注册。
方法：患者报告疼痛缓解，功能改进，在ECAP研究中,对132名接受试验刺激期的参与者在试验程序当天(第0天)和试验结束(EOT)之间进行永久性植入的意愿进行了比较.在应答者组之间比较从第0天和EOT开始的基于ECAP的神经生理学测量。
结果：实现了高阳性预测值（PPV），其中98.4％（60/61）在第0天评估成功的患者在EOT时也有反应。假阳性率(FPR)为5.6%(1/18)。通过所有第0天成功标准（“第0天成功”）的患者和未通过（“需要更长的时间来评估治疗”）的患者之间基于ECAP的神经生理学措施没有差异。然而,在EOT,与无应答者相比,应答者的治疗使用率和剂量水平更高.
结论：第0天的高PPV和低FPR评估为早在手术当天预测试验结果提供了信心。第0天的试验可能有利于减少与延长试验相关的患者负担和并发症发生率。ECAP剂量控制CL-SCS治疗可提供客观数据和快速缓解疼痛，以提高SCS试验预测预后的能力。
背景：ECAP研究已在ClinicalTrials.gov（NCT04319887）注册。
