{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:58:35Z","timestamp":1792803515902,"version":"4.5.0"},"reference-count":29,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2024,3,15]],"date-time":"2024-03-15T00:00:00Z","timestamp":1710460800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100019593","name":"Saluda Medical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100019593","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Reg Anesth Pain Med"],"accepted":{"date-parts":[[2024,2,20]]},"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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\u2009months to evaluate the ECAP dose and accuracy that sustained the durability of clinical improvements.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>41 patients randomized to CL-SCS remained in their treatment allocation and were followed up through 36\u2009months. Objective neurophysiological data, including measures of spinal cord activation, were analyzed. Pain relief was assessed by determining the proportion of patients with \u226550%\u2009and \u226580% reduction in overall back and leg pain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The performance of the feedback loop resulted in high-dose accuracy by keeping the elicited ECAP within 4\u00b5V of the target ECAP set on the system across all timepoints. Percent time stimulating above the ECAP threshold was &gt;98%,\u2009and the ECAP dose was \u226519.3\u00b5V. Most patients obtained \u226550% reduction (83%) and \u226580% 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\u2009and p=0.405, respectively).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rapm-2024-105370","type":"journal-article","created":{"date-parts":[[2024,3,15]],"date-time":"2024-03-15T10:50:34Z","timestamp":1710499834000},"page":"495-502","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["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"],"prefix":"10.1136","volume":"50","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3823-9610","authenticated-orcid":false,"given":"Nagy A","family":"Mekhail","sequence":"first","affiliation":[{"name":"Evidence-Based Pain Management Research, Cleveland Clinic, Cleveland, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert M","family":"Levy","sequence":"additional","affiliation":[{"name":"Anesthesia Pain Care Consultants, Boca Raton, Florida, 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H","family":"Burgher","sequence":"additional","affiliation":[{"name":"HOPE Research Institute, Phoenix, Arizona, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason E","family":"Pope","sequence":"additional","affiliation":[{"name":"Evolve Restorative Center, Santa Rosa, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher A","family":"Gilmore","sequence":"additional","affiliation":[{"name":"Carolinas Pain Institute, Winston-Salem, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Farooq A","family":"Qureshi","sequence":"additional","affiliation":[{"name":"St Luke\u2019s Spine & Pain Associates, Easton, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter S","family":"Staats","sequence":"additional","affiliation":[{"name":"National Spine and Pain Centers, Shrewsbury, New Jersey, 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