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dc.contributor.authorRusso Men_US
dc.contributor.authorCousins Men_US
dc.contributor.authorBrooker Cen_US
dc.contributor.authorTaylor Nen_US
dc.contributor.authorBoesel Ten_US
dc.contributor.authorSullivan Ren_US
dc.contributor.authorPoree Len_US
dc.contributor.authorShariati NHen_US
dc.contributor.authorHanson Een_US
dc.contributor.authorParker Jen_US
dc.description.abstractOBJECTIVES: Conventional spinal cord stimulation (SCS) delivers a fixed-input of energy into the dorsal column. Physiologic effects such as heartbeat, respiration, spinal cord movement, and history of stimulation can cause both the perceived intensity and recruitment of stimulation to increase or decrease, with clinical consequences. A new SCS system controls stimulation dose by measuring the recruitment of fibers in the dorsal column and by using the amplitude of the evoked compound action potentials (ECAPs) to maintain stimulation within an individualized therapeutic range. Safety and efficacy of this closed-loop system was evaluated through six-month postimplantation. MATERIALS AND METHODS: Chronic pain subjects with back and/or leg pain who were successfully trialed received a permanent system (Evoke; Saluda Medical, Sydney, Australia). Ratings of pain (100-mm visual analogue scale [VAS] and Brief Pain Instrument [BPI]), quality of life (EuroQol instrument [EQ-5D-5L]), function (Oswestry Disability Index [ODI]), and sleep (Pittsburgh Sleep Quality Index [PSQI]) were collected at baseline and repeated three and six months after implantation. RESULTS: Fifty-one subjects underwent a trial procedure; permanent implants were placed in 36 subjects. The proportion of subjects with ≥50% relief was 92.6% (back) and 91.3% (leg) at three months, and 85.7% (back) and 82.6% (leg) at six months. The proportion with ≥80% pain relief was 70.4% (back) and 56.5% (leg) at three months, and 64.3% (back) and 60.9% (leg) at six months. Statistically significant improvements in mean BPI, EQ-5D-5L, ODI, and PSQI were also observed at both time points. CONCLUSIONS: The majority of subjects experienced profound pain relief at three and six months, providing preliminary evidence for the effectiveness of the closed-loop SCS system. The exact mechanism of action for these outcomes is still being explored, although one likely hypothesis holds that ECAP feedback control may minimize recruitment of Aβ nociceptors and Aδ fibers during daily use of SCS.en_US
dc.subjectEvoked Compound Action Potential (ECAP)en_US
dc.subjectSpinal Cord Stimulationen_US
dc.subjectback painen_US
dc.subjectclosed loopen_US
dc.subjectfeedback stimulationen_US
dc.titleEffective Relief of Pain and Associated Symptoms With Closed‐Loop Spinal Cord Stimulation System: Preliminary Results of the Avalon Studyen_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleNeuromodulation: Technology at the Neural Interfaceen_US
dc.description.affiliatesHunter Pain Clinic, Broadmeadow, NSW, Australiaen_US
dc.description.affiliatesPain Management Research Institute and Kolling Institute, University of Sydney at the Royal North Shore Hospital, St Leonards, NSW, Australiaen_US
dc.description.affiliatesDepartment of Pain Medicine, Royal North Shore Hospital, St Leonards, NSW, Australiaen_US
dc.description.affiliatesNorthern Clinical School, University of Sydney, Sydney, NSW, Australiaen_US
dc.description.affiliatesNorthern Private Pain Centre, St. Leonards, NSW, Australiaen_US
dc.description.affiliatesInner West Pain Center, Newtown, NSW, Australiaen_US
dc.description.affiliatesPrecision Brain, Spine, and Pain Centre, Kew, VIC, Australiaen_US
dc.description.affiliatesUniversity of California, San Francisco, CA, USAen_US
dc.description.affiliatesSaluda Medical Pty Ltd., Artarmon, NSW, Australiaen_US
dc.description.affiliatesGraduate School of Biomedical Engineering, University of New South Wales, Kensington, NSW, Australiaen_US
dc.type.studyortrialProspective Cohort Studyen_US
dc.identifier.studynameACTRN12615000713594: Avalon Studyen_US
item.openairetypeJournal Article-
item.fulltextWith Fulltext-
Appears in Collections:Scholarly and Clinical
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