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
{"title":"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。","authors":"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","doi":"10.1007/s40122-024-00631-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1173-1185"},"PeriodicalIF":4.1000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393271/pdf/","citationCount":"0","resultStr":"{\"title\":\"Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy.\",\"authors\":\"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\",\"doi\":\"10.1007/s40122-024-00631-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).</p>\",\"PeriodicalId\":19908,\"journal\":{\"name\":\"Pain and Therapy\",\"volume\":\" \",\"pages\":\"1173-1185\"},\"PeriodicalIF\":4.1000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393271/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pain and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40122-024-00631-4\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/9 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40122-024-00631-4","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/9 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy.
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).
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.
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