Multicenter, Randomized, Double‐Blind Study Protocol Using Human Spinal Cord Recording Comparing Safety, Efficacy, and Neurophysiological Responses Between Patients Being Treated With Evoked Compound Action Potential–Controlled Closed‐Loop Spinal Cord Stimulation or Open‐Loop Spinal Cord Stimulation

The spinal cord (SC) response to stimulation has yet to be studied in a pivotal clinical study. We report the study design of an ongoing multicenter, randomized, double‐blind, controlled, parallel‐arm study of an evoked compound action potential (ECAP) controlled closed‐loop spinal cord stimulation (SCS) system, which aims to gain U.S. Food and Drug Administration approval.

[1]  Argumento da Epístola.  On Man , 2020, Behind the Geometrical Method.

[2]  M. Oh,et al.  Spinal Cord Stimulator Explantation: Motives for Removal of Surgically Placed Paddle Systems , 2018, Pain practice : the official journal of World Institute of Pain.

[3]  John L. Parker,et al.  Effective Relief of Pain and Associated Symptoms With Closed‐Loop Spinal Cord Stimulation System: Preliminary Results of the Avalon Study , 2018, Neuromodulation (Malden, Mass.).

[4]  K. Slavin,et al.  Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform , 2018, Neuromodulation : journal of the International Neuromodulation Society.

[5]  J. de Andrés,et al.  Prospective, Randomized Blind Effect-on-Outcome Study of Conventional vs High-Frequency Spinal Cord Stimulation in Patients with Pain and Disability Due to Failed Back Surgery Syndrome , 2017, Pain medicine.

[6]  J. Vesper,et al.  Therapy‐Related Explants After Spinal Cord Stimulation: Results of an International Retrospective Chart Review Study , 2017, Neuromodulation : journal of the International Neuromodulation Society.

[7]  T. Deer,et al.  Multicenter Retrospective Study of Neurostimulation With Exit of Therapy by Explant , 2017, Neuromodulation : journal of the International Neuromodulation Society.

[8]  Scott F Lempka,et al.  Randomized clinical trial of deep brain stimulation for poststroke pain , 2017, Annals of neurology.

[9]  Danielle M. Santarelli,et al.  High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience. , 2016, Pain physician.

[10]  P. Croft,et al.  Prevalence of chronic pain in the UK: a systematic review and meta-analysis of population studies , 2016, BMJ Open.

[11]  R. Coffey.  The Enduring Vitality of Implausible Claims for Neurostimulation and Psychosurgical Therapies , 2015, Stereotactic and Functional Neurosurgery.

[12]  Thomas L Yearwood,et al.  Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial , 2015, Anesthesiology.

[13]  M. Fitzpatrick.  Relief , 2015, Black '47 and Beyond.

[14]  Jens Volkmann,et al.  Short pulse width widens the therapeutic window of subthalamic neurostimulation , 2015, Annals of clinical and translational neurology.

[15]  F. Huygen,et al.  Lack of Body Positional Effects on Paresthesias When Stimulating the Dorsal Root Ganglion (DRG) in the Treatment of Chronic Pain , 2015, Neuromodulation : journal of the International Neuromodulation Society.

[16]  Warren M. Grill,et al.  Mechanisms and models of spinal cord stimulation for the treatment of neuropathic pain , 2014, Brain Research.

[17]  D. Abejón,et al.  Improving Patient Experience with Spinal Cord Stimulation: Implications of Position‐Related Changes in Neurostimulation , 2014, Neuromodulation : journal of the International Neuromodulation Society.

[18]  Jonathan Scott,et al.  Compact Nonlinear Model of an Implantable Electrode Array for Spinal Cord Stimulation (SCS) , 2014, IEEE Transactions on Biomedical Circuits and Systems.

[19]  A. Machado,et al.  Deep brain stimulation of the ventral striatum/anterior limb of the internal capsule in thalamic pain syndrome: study protocol for a pilot randomized controlled trial , 2013, Trials.

[20]  John L. Parker,et al.  Electrically Evoked Compound Action Potentials Recorded From the Sheep Spinal Cord , 2013, Neuromodulation : journal of the International Neuromodulation Society.

[21]  Patrick Richard,et al.  The economic costs of pain in the United States. , 2012, The journal of pain : official journal of the American Pain Society.

[22]  Yuichi Hoshino,et al.  Ultrasonographic quantification of spinal cord and dural pulsations during cervical laminoplasty in patients with compressive myelopathy , 2012, European Spine Journal.

[23]  Yun Guan,et al.  Spinal Cord Stimulation: Neurophysiological and Neurochemical Mechanisms of Action , 2012, Current Pain and Headache Reports.

[24]  Dean M. Karantonis,et al.  Compound action potentials recorded in the human spinal cord during neurostimulation for pain relief , 2012, PAIN.

[25]  R. Meyer,et al.  Bipolar spinal cord stimulation attenuates mechanical hypersensitivity at an intensity that activates a small portion of A-fiber afferents in spinal nerve-injured rats , 2011, Neuroscience.

[26]  Krishna Kumar,et al.  Spinal Cord Stimulation Is Effective in Management of Complex Regional Pain Syndrome I: Fact or Fiction , 2011, Neurosurgery.

[27]  J. Henderson,et al.  Spinal Cord Stimulation Versus Re‐operation in Patients With Failed Back Surgery Syndrome: An International Multicenter Randomized Controlled Trial (EVIDENCE Study) , 2011, Neuromodulation : journal of the International Neuromodulation Society.

[28]  Richard E. White,et al.  Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations , 2010, PAIN®.

[29]  M. Ranger,et al.  Changing body position alters the location of the spinal cord within the vertebral canal: a magnetic resonance imaging study. , 2008, British journal of anaesthesia.

[30]  Ron Goeree,et al.  Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial) , 2008, European journal of pain.

[31]  J. Farrar,et al.  Identifying important outcome domains for chronic pain clinical trials: An IMMPACT survey of people with pain , 2008, PAIN®.

[32]  Richard B. North,et al.  Neural Interface Devices: Spinal Cord Stimulation Technology , 2008, Proceedings of the IEEE.

[33]  Deena Skolnick Weisberg,et al.  The Seductive Allure of Neuroscience Explanations , 2008, Journal of Cognitive Neuroscience.

[34]  David Cella,et al.  Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. , 2008, The journal of pain : official journal of the American Pain Society.

[35]  R. Deyo,et al.  Spinal cord stimulation: Stimulating questions , 2007, Pain.

[36]  E. Buchser,et al.  Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicentre randomised controlled trial in patients with failed back surgery syndrome , 2007, Pain.

[37]  Robert J Coffey,et al.  Neurostimulation for chronic noncancer pain: an evaluation of the clinical evidence and recommendations for future trial designs. , 2006, Journal of neurosurgery.

[38]  J. Ioannidis.  Why Most Published Research Findings Are False , 2005, PLoS medicine.

[39]  S. Piantadosi,et al.  Spinal Cord Stimulation versus Repeated Lumbosacral Spine Surgery for Chronic Pain: A Randomized, Controlled Trial , 2005, Neurosurgery.

[40]  R. Deyo,et al.  Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications , 2004, Pain.

[41]  J. Farrar,et al.  Core outcome measures for chronic pain clinical trials: IMMPACT recommendations , 2003, Pain.

[42]  M. Bushnell,et al.  Analgesic and placebo effects of thalamic stimulation , 2003, Pain.

[43]  F. Keil.  Folkscience: coarse interpretations of a complex reality , 2003, Trends in Cognitive Sciences.

[44]  F. Mauguière,et al.  Predictive Value of Somatosensory Evoked Potentials for Long-lasting Pain Relief after Spinal Cord Stimulation: Practical Use for Patient Selection , 2003, Neurosurgery.

[45]  J. Oakley,et al.  Spinal Cord Stimulation: Mechanisms of Action , 2002, Spine.

[46]  Leonid Rozenblit,et al.  The misunderstood limits of folk science: an illusion of explanatory depth , 2002, Cogn. Sci..

[47]  J Holsheimer,et al.  Morphometry of human superficial dorsal and dorsolateral column fibres: significance to spinal cord stimulation. , 2002, Brain : a journal of neurology.

[48]  K. Burchiel.  Deep brain stimulation for chronic pain: the results of two multi-center trials and a structured review. , 2001, Pain medicine (Malden, Mass.).

[49]  John T. Jost,et al.  What makes you think you're so popular? Self-evaluation maintenance and the subjective side of the "friendship paradox" , 2001 .

[50]  J. Kruger,et al.  Unskilled and unaware of it: how difficulties in recognizing one's own incompetence lead to inflated self-assessments. , 1999, Journal of personality and social psychology.

[51]  Terrance Odean,et al.  Volume, Volatility, Price, and Profit When All Traders are Above Average , 1998 .

[52]  W A Wesselink,et al.  Effect of anode-cathode configuration on paresthesia coverage in spinal cord stimulation. , 1997, Neurosurgery.

[53]  J. Turner,et al.  Spinal cord stimulation for chronic low back pain: a systematic literature synthesis. , 1995, Neurosurgery.

[54]  R A Deyo,et al.  The importance of placebo effects in pain treatment and research. , 1994, JAMA.

[55]  M. Bushnell,et al.  The effects of dorsal column stimulation on measures of clinical and experimental pain in man , 1991, PAIN.

[56]  M. Bazerman,et al.  The Effects of Framing and Negotiator Overconfidence on Bargaining Behaviors and Outcomes , 1985 .

[57]  K. Cross.  Not can, but will college teaching be improved? , 1977 .

[58]  P. Nathan,et al.  Testing the gate-control theory of pain in man , 1974, Journal of neurology, neurosurgery, and psychiatry.

[59]  J. Mortimer,et al.  Electrical Inhibition of Pain by Stimulation of the Dorsal Columns: Preliminary Clinical Report , 1967, Anesthesia and analgesia.

[60]  Shealy Cn,et al.  Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. , 1967 .

[61]  P. Wall,et al.  Pain mechanisms: a new theory. , 1965, Science.

[62]  H. S. Gasser,et al.  THE COMPOUND NATURE OF THE ACTION CURRENT OF NERVE AS DISCLOSED BY THE CATHODE RAY OSCILLOGRAPH , 1924 .

[63]  L. Manchikanti,et al.  Effectiveness of Spinal Cord Stimulation in Chronic Spinal Pain: A Systematic Review. , 2016, Pain physician.

[64]  S. Palmisani,et al.  High‐Frequency Spinal Cord Stimulation for the Treatment of Chronic Back Pain Patients: Results of a Prospective Multicenter European Clinical Study , 2013, Neuromodulation : journal of the International Neuromodulation Society.

[65]  C. Burt,et al.  Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 2001-02. , 2006, Vital and health statistics. Series 13, Data from the National Health Survey.