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Cited by 95Pain Management and TreatmentNeurological disorders and treatmentsSpinal Cord Injury Research

Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study

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Russo, Marc, Brooker, Charles, Cousins, Michael J, Taylor, Nathan, Boesel, Tillman, Sullivan, Richard, Holford, Lewis, Hanson, Erin +4 more·2020·Neurosurgery
DOI 10.1093/neuros/nyaa003PMC PMC8184296
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Abstract

BACKGROUND: Spinal cord stimulation (SCS) activates the dorsal column fibers using electrical stimuli. Current SCS systems function in fixed-output mode, delivering the same stimulus regardless of spinal cord (SC) activation. OBJECTIVE: To present long-term outcomes of a novel closed-loop SCS system that aims to maintain the SC activation near a set target level and within a therapeutic window for each patient. SC activation is measured through the evoked compound action potential (ECAP) generated by each stimulus pulse. METHODS: Fifty patients with lower back and/or leg pain who were successfully trialed received a permanent system (Evoke; Saluda Medical, Sydney, Australia). Ratings of pain (visual analog scale), quality of life, function, sleep, and medication use were collected at baseline and at each visit. SC activation levels were reported in summary statistics. The therapeutic window for each individual patient was defined as the range of ECAP amplitudes between sensation threshold and uncomfortably strong stimulation. RESULTS: At 12 mo, the proportion of patients with ≥50% relief was 76.9% (back), 79.3% (leg), and 81.4% (overall), and the proportion with ≥80% pain relief was 56.4% (back), 58.6% (leg), and 53.5% (overall). Patients spent a median of 84.9% of their time with stimulation in their therapeutic window, and 68.8% (22/32) eliminated or reduced their opioid intake. Statistically significant improvements in secondary outcomes were observed. CONCLUSION: The majority of patients experienced more than 80% pain relief with stable SC activation, as measured by ECAP amplitude at 12 mo, providing evidence for the long-term effectiveness of the Evoke closed-loop SCS system.

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  • Today, neurotech is most often developed or used within clinical sciences and healthcare to monitor and treat chronic illnesses or injuries, including Parkinson's disease, chronic pain, epilepsy, and depression.

    “Today, neurotech is most often developed or used within the clinical sciences and healthcare spaces to monitor and treat a gamut of chronic illnesses or injuries spanning neurological and psychological ailments, including Parkinson's disease (deep brain stimulation 16 ), chronic pain (spinal cord stimulation 35 ), epilepsy (neuropace), depression (transcranial direct current stimulation 25 ), and”

    From AI and Neurotechnology (2023) · cites this paper as [35]

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  1. [1]Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns. Anesth Analg. 1967; 46(4): 489- 491. 4952225
  2. [2]Sdrulla AD, Guan Y, Raja SN. Spinal cord stimulation: clinical efficacy and potential mechanisms. Pain Pract. 2018; 18 (8): 1048- 1067. 29526043 PMC6391880
  3. [3]Kimura A, Seichi A, Inoue H et al. Ultrasonographic quantification of spinal cord and dural pulsations during cervical laminoplasty in patients with compressive myelopathy. Eur Spine J. 2012; 21(12): 2450- 2455. 22820915 PMC3508211
  4. [4]Ranger MRB, Irwin GJ, Bunbury KM, Peutrell JM. Changing body position alters the location of the spinal cord within the vertebral canal: a magnetic resonance imaging study. Br J Anaesth. 2008; 101(6): 804- 809. 18936040
  5. [5]Ross E, Abejón D. Improving patient experience with spinal cord stimulation: implications of position-related changes in neurostimulation. Neuromodulation. 2014; 17(S1): 36- 41. 22133264
  6. [6]Parker JL, Karantonis DM, Single PS et al. Electrically evoked compound action potentials recorded from the sheep spinal cord. Neuromodulation. 2013; 16(4): 295- 303; discussion 303. 23844589
  7. [7]Halonen J-P, Jones SJ, Edgar MA, Ransford AO. Conduction properties of epidurally recorded spinal cord potentials following lower limb stimulation in man. Electroencephalogr Clin Neurophysiol. 1989; 74(3): 161- 174. 2470572
  8. [8]Nashmi R, Fehlings MG. Changes in axonal physiology and morphology after chronic compressive injury of the rat thoracic spinal cord. Neuroscience. 2001; 104(1): 235- 251. 11311546
  9. [9]Russo M, Cousins MJ, Brooker C et al. Effective relief of pain and associated symptoms with closed-loop spinal cord stimulation system: preliminary results of the Avalon study. Neuromodulation. 2018; 21(1): 38- 47. 28922517
  10. [12]Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine. 2000; 25(22): 2940- 2953; discussion 2952. 11074683
  11. [13]Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989; 28(2): 193- 213. 2748771
  12. [14]EuroQol Group. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy. 1990; 16(3): 199- 208. 10109801
  13. [15]Parker JL, Karantonis DM, Single PS, Obradovic M, Cousins MJ. Compound action potentials recorded in the human spinal cord during neurostimulation for pain relief. Pain. 2012; 153(3): 593- 601. 22188868
  14. [16]North RB. Neural interface devices: spinal cord stimulation technology. Proc IEEE. 2008; 96(7): 1108- 1119.
  15. [17]Oakley JC, Prager JP. Spinal cord stimulation. Spine. 2002; 27(22): 2574- 2583. 12435996
  16. [18]Murphy KR, Han JL, Hussaini SMQ et al. The volume-outcome effect: impact on trial-to-permanent conversion rates in spinal cord stimulation. Neuromodulation. 2017; 20(3): 256- 262. 27696607 PMC5378689
  17. [19]Huang KT, Martin J, Marky A et al. A national survey of spinal cord stimulation trial-to-permanent conversion rates. Neuromodulation. 2015; 18(2): 133- 140. 24930992
  18. [20]Kapural L, Yu C, Doust MW 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. Anesthesiology. 2015; 123(4): 851- 860. 26218762
  19. [21]Deer T, Slavin KV, Amirdelfan K et al. Success using neuromodulation with BURST (SUNBURST) study: results from a prospective, randomized controlled trial using a novel burst waveform. Neuromodulation. 2018; 21(1): 56- 66. 28961366
  20. [23]Buysse DJ, Germain A, Moul DE et al. Efficacy of brief behavioral treatment for chronic insomnia in older adults. Arch Intern Med. 2011; 171(10): 887- 895. 21263078 PMC3101289
  21. [24]Kumar K, Taylor RS, Jacques L et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008; 63(4): 762- 770. 18981888
  22. [25]Holsheimer J. Effectiveness of spinal cord stimulation in the management of chronic pain: analysis of technical drawbacks and solutions. Neurosurgery. 1997; 40(5): 990- 999. 9149258
  23. [26]Van Buyten J-P, Wille F, Smet I et al. Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study. Neuromodulation. 2017; 20(7): 642- 649. 28834092 PMC5656934
  24. [27]Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation. 2015; 18(7): 603- 609. 26053499
  25. [28]Dupré DA, Tomycz N, Whiting D, Oh M. Spinal cord stimulator explantation: motives for removal of surgically placed paddle systems. Pain Pract. 2018; 18(4): 500- 504. 28875558
  26. [29]Pope JE, Deer TR, Falowski S et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation. 2017; 20(6): 543- 552. 28714533
  27. [30]Hagemeier NE. Introduction to the opioid epidemic: the economic burden on the healthcare system and impact on quality of life. Am J Manag Care. 2018; 24(10 suppl): S200- S206. 29851449

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Authors
Russo, M., Brooker, C., Cousins, M. J., Taylor, N., Boesel, T., Sullivan, R., Holford, L., Hanson, E., Gmel, G. E., Shariati, N. H., Poree, L., & Parker, J.
Affiliations
  • Hunter Pain Clinic, Broadmeadow, Australia
  • MJC Pain Management and Research Centre, St. Leonards, Australia
  • Inner West Pain Center, Newtown, Australia
  • Precision Brain, Spine, and Pain Centre, Kew, Australia
  • Saluda Medical (Australia) (AU)
  • University of California, San Francisco (US)
  • UNSW Sydney (AU)
Corresponding author
Gmel, Gerrit Eduard
ORCID
Venue
Neurosurgery
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2020-02-05
Volume
87
Issue
4
Pages
E485-E495
ISSN
  • 0148-396X (ISSN-L)
  • 1524-4040
DOI
10.1093/neuros/nyaa003
PMC
PMC8184296
OpenAlex
W3004889884
Cited by
95
References
3
Citations by year
2026: 15 · 2025: 7 · 2024: 18 · 2023: 19 · 2022: 13 · 2021: 17 · 2020: 6
FWCI
16.07
Type
journal article
Language
en
Open access
Licence
Locations
  • Neurosurgery (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
Topics
  • Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
  • Health Sciences › Medicine › Neurology › Neurological disorders and treatments
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Spinal Cord Injury Research
Keywords
evoked compound action potential, spinal cord stimulation, chronic low back pain, leg pain, analgesia, opioid dose reduction, therapeutic window, long-term outcomes
MeSH terms
Adult, Aged, Female, Humans, Male, Middle Aged, Pain Measurement, Prospective Studies, Quality of Life, Spinal Cord, Time Factors, Treatment Outcome, Chronic Pain, Pain Management, Spinal Cord Stimulation

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