{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T19:19:12Z","timestamp":1789672752965,"version":"4.0.1"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2025,5,16]],"date-time":"2025-05-16T00:00:00Z","timestamp":1747353600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,11,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Spinal cord stimulation (SCS) systems that deliver fixed amplitudes expose target tissue to varying electrical fields due to the changing lead-to-cord distance accompanying postural shifts and other body movements. Inconsistent stimulation results in periods of overstimulation or under-stimulation perceived by patients as discomfort or potentially inadequate pain relief. CL-SCS may be applied to provide a comfortable level of perception down to imperceptible stimulation, commonly preferred in higher frequency and multiplexed programming. Here we report outcomes from a study evaluating a closed-loop (CL) SCS system that uses spinal evoked compound action potentials to adjust stimulation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This ongoing study combines the evaluation of pain-related outcomes (for \u226424\u2009months) with in-clinic randomized, crossover testing of CL performance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Sixty subjects have been implanted with the CL-SCS system, and 54 subjects have completed the 3-month visit. Sixty percent preferred below-perception waveforms for therapy during at-home use. The study successfully met its primary endpoint with 89.3% of subjects in the Primary Analysis Set (n\u2009=\u200928) reporting reduction in overstimulation with CL-SCS relative to OL-SCS at 1 month (P\u2009&amp;lt;\u2009.001; binomial exact test); at 3 months, 86% of subjects with low-back\/leg pain (n\u2009=\u200951); and all 3 with upper limb pain reported \u226550% reduction in pain, relative to baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The data presented here support the performance of a flexible CL-SCS system that can deliver a variety of waveforms, with amplitude programmed to patient comfort and automatically adjusted up to 50 times per second, to improve the consistency of therapy experience.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration<\/jats:title>\n                    <jats:p>This study is registered on ClinicalTrials.gov number NCT05177354 https:\/\/clinicaltrials.gov\/search? term=NCT05177354<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/pm\/pnaf058","type":"journal-article","created":{"date-parts":[[2025,5,16]],"date-time":"2025-05-16T07:59:33Z","timestamp":1747382373000},"page":"773-782","source":"Crossref","is-referenced-by-count":13,"title":["Early outcomes with a flexible ECAP based closed loop using multiplexed spinal cord stimulation waveforms\u2014single-arm study with in-clinic randomized crossover testing"],"prefix":"10.1093","volume":"26","author":[{"given":"Vahid","family":"Mohabbati","sequence":"first","affiliation":[{"name":"Sydney Pain Research Center , Wahroonga, NSW 2076,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Sullivan","sequence":"additional","affiliation":[{"name":"Precision Brain Spine & Pain Centre , Kew, VIC 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