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. 2024 Oct;13(5):1173-1185.
doi: 10.1007/s40122-024-00631-4. Epub 2024 Jul 9.

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

Jason E Pope  1 , Ajay Antony  2 , Erika A Petersen  3 , Steven M Rosen  4 , Dawood Sayed  5 , Corey W Hunter  6 , Johnathan H Goree  3 , Chau M Vu  7 , Harjot S Bhandal  7 , Philip M Shumsky  7 , Todd A Bromberg  4 , G Lawson Smith  3 , Christopher M Lam  5 , Hemant Kalia  8 , Jennifer M Lee  9 , Abeer Khurram  10 , Ian Gould  10 , Dean M Karantonis  10 , Timothy R Deer  11
Affiliations

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

Jason E Pope et al. Pain Ther. 2024 Oct.

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).

Keywords: Closed loop; ECAP; Evoked compound action potential; Neuromodulation; SCS; Spinal cord stimulation.

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Conflict of interest statement

Jason E. Pope reports research and consulting fees from Saluda Medical during the conduct of the study; consultancy for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil outside the submitted work; has received grant and research support from: Abbott, Flowonix, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil outside the submitted work; and is a minority shareholder of Vertos, Stimgenics, SPR Therapeutics, Saluda Medical, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, Abbott and Anesthetic Gas Reclamation. Ajay Antony serves as a consultant/speaker for Boston Scientific, Abbott, Nalu, PainTEQ, Saluda, Vertos; he has received research support from ViaDISC, Abbott, Boston scientific, PainTEQ, Saluda, and SPR. Erika A. Petersen has received research support from Mainstay, Medtronic, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda Medical outside the submitted work, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda Medical, and Vertos outside the submitted work. She holds stock options from SynerFuse and neuro42. There are no other relationships that might lead to a conflict of interest in the current study. Steven M. Rosen reports research and consulting fees from Saluda Medical during the conduct of the study. Dawood Sayed reports personal fees from Abbott, Boston Scientific, Flowonix, Medtronic, Nevro, Saluda, and Vertiflex, personal fees and stock options from Mainstay, SPR Therapeutics, PainTEQ, and Vertos, and stock options from Neuralace and Surgentec. Corey W. Hunter reports grants from Saluda Medical during the conduct of the study and consultancy fees from Genecentrix outside the submitted work. Johnathan H. Goree is a consultant for Saluda Medical, Abbott, and Stratus Medical and the recipient of research support paid to the institution by SPR Therapeutics and Mainstay Medical. Chau M. Vu serves as a consultant for Saluda Medical; consultant and principal investigator for PainTEQ. Harjot S. Bhandal serves as a consultant for Saluda Medica and principal investigator for Aurora Spine. Philip M. Shumsky serves as a consultant for Saluda Medical. Todd A. Bromberg reports research and consulting fees from Saluda Medical during the conduct of the study. He is also an advisor for and reports research fees from Medtronic. G. Lawson Smith and Christopher M. Lam report no conflicts of interest. Hemant Kalia serves as a consultant for Abbott, Nevro, Nalu, SPR Therapeutics, and Curonix. He serves on the medical advisory board for Abbott, Equanimity, Nervonik, and Virdio Health and reports research support from Abbott. Jennifer M. Lee is a consultant for and has received research support from Boston Scientific. Abeer Khurram, Ian Gould, and Dean M. Karantonis report being employees of Saluda Medical. Timothy R. Deer reports personal fees from Saluda Medical during the conduct of the study and consultancy for Axonics, Abbott, Nalu, Vertos, SpineThera, Mainstay, CornerLoc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTEQ, Tissue Tech, Spinal Simplicity, and Avanos outside the submitted work. He is a minor equity holder of Saluda Medical, Nalu, SpineThera, Stimgenics, Vertiflex, Vertos, and Bioness and an advisory board member of Abbott, Vertos, Nalu, SPR Therapeutics, and Tissue Tech.

Figures

Fig. 1
Fig. 1
Day 0 and EOT evaluations were performed for a subset of patients undergoing a traditional trial. EOT end of trial, HCP healthcare professional
See this image and copyright information in PMC

References

    1. Shanthanna H, Eldabe S, Provenzano DA, Bouche B, Buchser E, Chadwick R, et al. Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain. Reg Anesth Pain Med. 2023;48(6):273–87. 10.1136/rapm-2022-104097 - DOI - PMC - PubMed
    1. Food and Drug Administration. Medtronic, Inc.; Premarket approval of the Medtronic Itrel spinal cord stimulation system. 1984.
    1. FDA. Conduct a trial stimulation period before implanting a spinal cord stimulator (SCS)—letter to health care providers [Internet]. FDA. 2020 [cited 2023 Jan 3]. Available from: https://www.fda.gov/medical-devices/letters-health-care-providers/conduc...
    1. Thomson SJ, Tavakkolizadeh M, Love-Jones S, Patel NK, Gu JW, Bains A, et al. Effects of rate on analgesia in kilohertz frequency spinal cord stimulation: results of the PROCO randomized controlled trial. Neuromodul Technol Neural Interface 2018;21(1):67–76. - PMC - PubMed
    1. Metzger CS, Hammond MB, Paz-Solis JF, Newton WJ, Thomson SJ, Pei Y, et al. A novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain. Expert Rev Med Devices. 2021;18(3):299–306. 10.1080/17434440.2021.1890580 - DOI - PubMed

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