Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements With Closed-Loop Spinal Cord Stimulation.

Autor:	Levy RM; Neurosurgical Services, Clinical Research, Anesthesia Pain Care Consultants, Tamarac, FL, USA. Electronic address: rml199@northwestern.edu., Mekhail NA; Evidence-Based Pain Management Research, Neurologic Institute, Cleveland Clinic, Cleveland Ohio, OH, USA., Kapural L; Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA., Gilmore CA; Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA., Petersen EA; Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Goree JH; Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Pope JE; Evolve Restorative Center, Santa Rosa, CA, USA., Costandi SJ; Evidence-Based Pain Management Research, Neurologic Institute, Cleveland Clinic, Cleveland Ohio, OH, USA., Kallewaard JW; Department of Anaesthesiology and Pain Management, Rijnstate Hospital, Elst, The Netherlands; Department of Anesthesiology and Pain Medicine, Amsterdam University Medical Centre, Amsterdam, The Netherlands., Thomson S; Pain Medicine and Neuromodulation, Mid & South Essex University Hospitals, Essex, UK., Gilligan C; Robert Wood Johnson University Hospital, NJ, USA., AlFarra T; Department of Physical Medicine & Rehabilitation, Mount Sinai Hospital, New York, NY, USA., Broachwala MY; Department of Physical Medicine & Rehabilitation, Johns Hopkins School of Medicine, Baltimore, MD, USA., Chopra H; Department of Physical Medicine & Rehabilitation, Johns Hopkins School of Medicine, Baltimore, MD, USA., Hunter CW; Ainsworth Institute of Pain Management, New York, NY, USA., Rosen SM; Delaware Valley Pain and Spine Institute, Trevose, PA, USA., Amirdelfan K; IPM Medical Group, Walnut Creek, CA, USA., Falowski SM; Neurosurgical Associates of Lancaster, Lancaster, PA, USA., Li S; National Spine and Pain Centers, Shrewsbury, NJ, USA., Scowcroft J; KC Pain Centers, Lee's Summit, Missouri, MO, USA., Lad SP; Department of Neurosurgery, Duke University Medical Center, Durham, NC, USA., Sayed D; Department of Anesthesiology, University of Kansas School of Medicine, Kansas City, KS, USA., Antony A; The Orthopaedic Institute, Gainesville, FL, USA., Deer TR; The Spine and Nerve Center of the Virginias, Charleston, WV, USA., Hayek SM; Division of Pain Medicine, University Hospitals, Cleveland Medical Center, Cleveland, OH, USA., Guirguis MN; Ochsner Health System, New Orleans, LA, USA., Boeding RB; iSpine Clinics, Maple Grove, MN, USA., Calodney AK; Precision Spine Care, Tyler, TX, USA., Bruel B; Department of Physical Medicine and Rehabilitation, McGovern Medical School and Cy Pain and Spine PLLC, Houston, TX, USA., Buchanan P; Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA., Soliday N; Saluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia., Duarte RV; Saluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia; Department of Health Data Science, University of Liverpool, Liverpool, UK., Leitner A; Saluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia., Staats PS; National Spine and Pain Centers, Shrewsbury, NJ, USA.
Jazyk:	angličtina
Zdroj:	Neuromodulation : journal of the International Neuromodulation Society [Neuromodulation] 2024 Sep 09. Date of Electronic Publication: 2024 Sep 09.
DOI:	10.1016/j.neurom.2024.07.003
Abstrakt:	Objectives: Spinal cord stimulation (SCS) has been challenged by the lack of neurophysiologic data to guide therapy optimization. Current SCS programming by trial-and-error results in suboptimal and variable therapeutic effects. A novel system with a physiologic closed-loop feedback mechanism using evoked-compound action potentials enables the optimization of physiologic neural dose by consistently and accurately activating spinal cord fibers. We aimed to identify neurophysiologic dose metrics and their ranges that resulted in clinically meaningful treatment responses. Materials and Methods: Subjects from 3 clinical studies (n = 180) with baseline back and leg pain ≥60 mm visual analog scale and physical function in the severe to crippled category were included. Maximal analgesic effect (MAE) was operationally defined as the greatest percent reduction in pain intensity or as the greatest cumulative responder score (minimal clinically important differences [MCIDs]) obtained within the first 3 months of SCS implant. The physiologic metrics that produced the MAE were analyzed. Results: We showed that a neural dose regimen with a high neural dose accuracy of 2.8μV and dose ratio of 1.4 resulted in a profound clinical benefit to chronic pain patients (MAE of 79 ± 1% for pain reduction and 12.5 ± 0.4 MCIDs). No differences were observed for MAE or neurophysiological dose metrics between the trial phase and post-implant MAE visit. Conclusion: For the first time, an evidence-based neural dose regimen is available for a neurostimulation intervention as a starting point to enable optimization of clinical benefit, monitoring of adherence, and management of the therapy. Competing Interests: Conflict of Interest Robert M. Levy is an uncompensated consultant for Biotronik, Abbott, Nalu, Saluda, and Mainstay Medical and has stock options from Nalu and Saluda Medical. Nagy A. Mekhail reports receiving grants from Neuros, Mesoblast, and Vivex Biologics, as well as consulting as a medical monitor for Saluda Medical, Nevro, Vivex Biologics, Mainstay, Presidio Medical, and Vertos outside the submitted work. Leonardo Kapural 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. Christopher A. Gilmore reports personal fees and other assistance from SPR, and personal fees from Nevro, Nalu, Biotronik, Boston Scientific, and Saluda Medical outside the submitted work. 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. Jonathan H. Goree is a consultant for Saluda Medical, Abbott, and Stratus Medical outside the submitted work. He has received research support paid to the institution by SPR Therapeutics and Mainstay Medical. Jason E. Pope reports research and consulting fees from Saluda Medical during the conduct of the study; stock options from Saluda Medical; 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, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, Abbott and Anesthetic Gas Reclamation. Shrif J. Costandi reports receiving grants from Saluda Medical, Vertos, Mainstay, and Vivex outside the submitted work. Jan Willem Kallewaard is an advisory board member for Boston Scientific, Medtronic, Abbott, and Saluda Medical. Simon Thomson has received consultancy fees from Boston Scientific, Mainstay Medical, and Saluda Medica outside the submitted work. He has received department research funding from the National Institute for Health Research, Boston Scientific, Saluda Medical, and Mainstay Medical. Christopher Gilligan reports consulting fees and stock options received from Mainstay, personal fees from Mainstay, Saluda Medical, Persica, and Iliad outside the submitted work, research funded by Sollis, expert witness testimony fees, and serves as Editor-in-Chief of Pain Practice. Corey W. Hunter has received consultancy fees from Saluda Medical and Genecentrix outside the submitted work. Kasra Amirdelfan reports consultancy for Medtronic, Nevro, Boston Scientific, Nalu, Presidio, Biotronik, Mesoblast, and Vivex Laboratories outside the submitted work. Steven M. Falowski reports consulting fees from Abbott, Medtronic, Saluda, VertiFlex, Vertos, Surgentec, CornerLoc, Mainstay, and Relievant outside the submitted work, has received a 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. Sean Li reports receiving grants and personal fees from Saluda Medical during the conduct of the study; he reports grants from Avanos, Nalu Medical, SPR Therapeutics, Averitas Pharma, Biotronik, Neuralace, Presidio, SGX Therapeutics, and PainTeq, as well as consultancy for Abbott, Avanos, Presidio, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, PainTeq, and Vertos Medical outside the submitted work, as well as holding stock options for Nalu Medical and NeuroOne. Shivanand P. Lad reports personal fees from Mainstay Medical and Nevro outside the submitted work; he is a consultant for Abbott Laboratories, Boston Scientific, Higgs Boson Health, Medtronic, Minnetronix, Nevro, and Presidio Medical. Dawood Sayed reports personal fees from Abbott, Boston Scientific, Flowonix, Medtronic, Nevro, Saluda, and Vertiflex outside the submitted work, personal fees and stock options from Mainstay, SPR Therapeutics, PainTEQ, and Vertos, and stock options from Neuralace and Surgentec. Ajay Antony reports consultancy fees from Boston Scientific outside the submitted work. Timothy R. Deer reports consultancy for Axonics, Abbott, Nalu, Vertos, SpineThera, Mainstay, Cornerloc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTeq, Saluda Medical, Tissue Tech, Spinal Simplicity, and Avanos outside the submitted work. Maged N. Guirguis has received consulting fees from Avanos Medical, Avertis Pharmacy, Boston Scientific, and Saluda Medical outside the submitted work, as well as research support from Boston Scientific, Neuros Medical, Nevro Corp, and Saluda Medical outside the submitted work. Aaron K. Calodney reports personal fees from Medtronic, Nevro, Stryker, PainTeq, Saluda Medical, and Boston Scientific outside the submitted work. Brian Bruel reports consultancy for Saluda Medical, Boston Scientific, Spinal Simplicity, Biotronik, TerSera, Stratus, and Neurovasis outside the submitted work. Patrick Buchanan reports consulting fees from Saluda Medical, Abbott, and PainTEQ outside the submitted work. Nicole Soliday, Rui V. Duarte, and Angela Leitner report being employees of Saluda Medical. Peter S. Staats has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work, and has stock options from Saluda Medical and Nalu. The remaining authors report no conflict of interest. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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