Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain.

Autor:	Mekhail NA; Evidence-Based Pain Management Research, Cleveland Clinic, Cleveland, Ohio, USA mekhain@ccf.org., Levy RM; Anesthesia Pain Care Consultants, Boca Raton, Florida, USA., Deer TR; Spine and Nerve Center of the Virginias, Charleston, West Virginia, USA., Kapural L; Carolinas Pain Institute, Winston-Salem, North Carolina, USA., Li S; National Spine and Pain Centers, Shrewsbury, New Jersey, USA., Amirdelfan K; Integrated Pain Management Medical Group Inc, Walnut Creek, California, USA., Hunter CW; Ainsworth Institute of Pain Management, New York, New York, USA., Rosen SM; Delaware Valley Pain and Spine Institute, Trevose, Pennsylvania, USA., Costandi SJ; Evidence-Based Pain Management Research, Cleveland Clinic, Cleveland, Ohio, USA., Falowski SM; Argires-Marotti Neurosurgical Associates of Lancaster, Lancaster, Pennsylvania, USA., Burgher AH; HOPE Research Institute, Phoenix, Arizona, USA., Pope JE; Evolve Restorative Center, Santa Rosa, California, USA., Gilmore CA; Carolinas Pain Institute, Winston-Salem, North Carolina, USA., Qureshi FA; St Luke's Spine & Pain Associates, Easton, Pennsylvania, USA., Staats PS; National Spine and Pain Centers, Shrewsbury, New Jersey, USA., Scowcroft J; Pain Management Associates, Independence, Missouri, USA., McJunkin T; Arizona Pain, Glendale, Arizona, USA., Kim CK; Spine and Nerve Center of the Virginias, Charleston, West Virginia, USA., Yang MI; Summit Pain Alliance, Santa Rosa, California, USA., Stauss T; Pain Physicians of Wisconsin, Milwaukee, Wisconsin, USA., Rauck R; Carolinas Pain Institute, Winston-Salem, North Carolina, USA., Duarte RV; Department of Health Data Science, University of Liverpool, Liverpool, UK.; Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia., Soliday N; Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia., Leitner A; Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia., Hanson E; Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia., Ouyang Z; Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia., Mugan D; Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia., Poree L; University of California San Francisco, San Francisco, California, USA.
Jazyk:	angličtina
Zdroj:	Regional anesthesia and pain medicine [Reg Anesth Pain Med] 2024 Mar 15. Date of Electronic Publication: 2024 Mar 15.
DOI:	10.1136/rapm-2024-105370
Abstrakt:	Introduction: A novel, spinal cord stimulation (SCS) system with a physiologic closed-loop (CL) feedback mechanism controlled by evoked compound action potentials (ECAPs) enables the optimization of physiologic neural dose and the accuracy of the stimulation, not possible with any other commercially available SCS systems. The report of objective spinal cord measurements is essential to increase the transparency and reproducibility of SCS therapy. Here, we report a cohort of the EVOKE double-blind randomized controlled trial treated with CL-SCS for 36 months to evaluate the ECAP dose and accuracy that sustained the durability of clinical improvements. Methods: 41 patients randomized to CL-SCS remained in their treatment allocation and were followed up through 36 months. Objective neurophysiological data, including measures of spinal cord activation, were analyzed. Pain relief was assessed by determining the proportion of patients with ≥50% and ≥80% reduction in overall back and leg pain. Results: The performance of the feedback loop resulted in high-dose accuracy by keeping the elicited ECAP within 4µV of the target ECAP set on the system across all timepoints. Percent time stimulating above the ECAP threshold was >98%, and the ECAP dose was ≥19.3µV. Most patients obtained ≥50% reduction (83%) and ≥80% reduction (59%) in overall back and leg pain with a sustained response observed in the rates between 3-month and 36-month follow-up (p=0.083 and p=0.405, respectively). Conclusion: The results suggest that a physiological adherence to supra-ECAP threshold therapy that generates pain inhibition provided by ECAP-controlled CL-SCS leads to durable improvements in pain intensity with no evidence of loss of therapeutic effect through 36-month follow-up. Competing Interests: Competing interests: NM reports personal fees from Saluda Medical for acting as independent medical monitor for the EVOKE study during the conduct of the study; he reports receiving research grants from Neuros, Mesoblast, and Vivex Biologics, as well as consulting as a medical monitor of Nevro, Vivex Biologics, Mainstay, Sollis Therapeutics, and Vertos outside the submitted work. RL is an uncompensated consultant of Biotronik, Abbott, Nalu, Saluda, and Mainstay Medical and has stock options from Nalu and Saluda Medical. TD 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. LK reports receiving grants from Nevro, Neuros, Avanos, Medtronic, Neuralace, and Xalud Therapeutics and financial support from Nevro, Avanos, and Saluda Medical outside the submitted work. SL reports receiving grants and personal fees from Saluda Medical during the conduct of the study; he reports grants from Avanos, Boston Scientific, Nalu Medical, SPR Therapeutics, Averitas Pharma, Biotronik, SGX Therapeutics, and PainTEQ, as well as consultancy for Abbott, Avanos, Boston Scientific, Nevro, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, and PainTEQ, outside the submitted work, as well as holding stock options for Nalu Medical. KA reports consultancy for Medtronic, Nevro, Boston Scientific, Nalu, Presidio, Biotronik, Mesoblast, and Vivex Laboratories outside the submitted work. CH reports grants from Saluda Medical during the conduct of the study and consultancy fees from Genecentrix outside the submitted work. SC reports research grants from Saluda Medical to the Cleveland Clinic during the conduct of the study and grants from Vertos, Mainstay, and Vivex outside the submitted work. SMF reports consulting fees from Abbott, Medtronic, Saluda, VertiFlex, Vertos, Surgentec, CornerLoc, Mainstay, and Relievant outside the submitted work; has received grant for research funding from Mainstay, Relievant, Medtronic, Abbott, VertiFlex, Saluda, Nalu, CornerLoc, Aurora, Biotronik, and Stimgenics outside the submitted work; and has an equity position in SynerFuse, Aurora Spine, Thermaquil, SPR Therapeutics, Saluda, CornerLoc, PainTEQ, Stimgenics, Anesthetic Gas Reclamation, Neural Integrative Solutions, SpineThera, and Celeri Health. JP reports research and consulting fees from Saluda Medical during the conduct of the study and 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 shareholder of Vertos, SPR Therapeutics, PainTEQ, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, and Anesthetic Gas Reclamation. CG reports clinical trial funding from Saluda Medical during the conduct of the study and reports personal fees and others from SPR and personal fees from Nevro, Nalu, Biotronik, and Boston Scientific outside the submitted work. PSS has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work and has stock options from Saluda Medical and Nalu. JS reports personal fees from Nevro during the conduct of the study and personal fees from Saluda Medical and Boston Scientific outside the submitted work. TM reports research fees from Saluda Medical during the conduct of the study and personal fees from Nevro outside the submitted work. RR reports grants from SPR, Nalu, and Nevro outside the submitted work, personal fees from Presidio, and grants and personal fees from Boston Scientific and Saluda Medical outside the submitted work. RD, NS, AL, EH, ZO, and DM report being employees of Saluda Medical. LP reports personal fees from Saluda Medical, is a member of the data monitoring board of Saluda Medical during the conduct of the study, and reports personal consulting fees from Medtronic and Nalu outside the submitted work. No other disclosures were reported. (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)
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