Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy.

IF 4.1 2区医学 Q1 CLINICAL NEUROLOGY Pain and Therapy Pub Date : 2024-10-01 Epub Date: 2024-07-09 DOI:10.1007/s40122-024-00631-4

Jason E Pope, Ajay Antony, Erika A Petersen, Steven M Rosen, Dawood Sayed, Corey W Hunter, Johnathan H Goree, Chau M Vu, Harjot S Bhandal, Philip M Shumsky, Todd A Bromberg, G Lawson Smith, Christopher M Lam, Hemant Kalia, Jennifer M Lee, Abeer Khurram, Ian Gould, Dean M Karantonis, Timothy R Deer

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Abstract

Introduction: 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.

Trial registration: The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).

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利用 ECAP 剂量控制闭环疗法在术后编程后立即识别 SCS 试验应答者。

简介：固定输出脊髓刺激（SCS）筛选试验的缺点可能会导致试验结果打折扣，并且难以预测长期成功率。诱发复合动作电位（ECAP）剂量控制闭环（CL）脊髓刺激可以客观地确认治疗性神经激活和脉冲间刺激调整。我们报告了生理学 CL-SCS 后患者报告的即时治疗反应和神经生理学治疗反应，以及早期 SCS 试验反应预测的可行性：方法：我们比较了 132 名参加 ECAP 研究并接受刺激试验的患者在试验过程当天（第 0 天）和试验结束时（EOT）的疼痛缓解情况、功能改善情况以及是否愿意接受永久植入治疗。结果显示，阳性预测值（PPD）和阴性预测值（PPD）均较高，而阴性预测值（PPD）和阳性预测值（PPD）均较低：阳性预测值（PPV）很高，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）。通过第 0 天所有成功标准（"第 0 天成功"）和未通过标准（"需要更长时间评估疗法"）的患者之间，基于 ECAP 的神经生理学测量结果没有差异。然而，在 EOT 时，与无反应者相比，有反应者的治疗用量和剂量水平更高：结论：第0天评估的高PPV和低FPR为早在手术当天预测试验结果提供了信心。第0天试验可能有利于减轻患者负担，降低与延长试验相关的并发症发生率。ECAP剂量控制CL-SCS疗法可提供客观数据和快速起效的疼痛缓解，从而提高SCS试验预测结果的预后能力：ECAP研究已在ClinicalTrials.gov（NCT04319887）注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pain and Therapy CLINICAL NEUROLOGY-

CiteScore

6.60

自引率

5.00%

发文量

110

审稿时长

6 weeks

期刊介绍： Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.