{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T01:15:04Z","timestamp":1792804504913,"version":"4.5.0"},"reference-count":33,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,7,13]],"date-time":"2020-07-13T00:00:00Z","timestamp":1594598400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The RNS System is a direct brain\u2010responsive neurostimulation system that is US Food and Drug Administration\u2013approved for adults with medically intractable focal onset seizures based on safety and effectiveness data from controlled clinical trials. The purpose of this study was to retrospectively evaluate the real\u2010world safety and effectiveness of the RNS System.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Eight comprehensive epilepsy centers conducted a chart review of patients treated with the RNS System for at least 1\u00a0year, in accordance with the indication for use. Data included device\u2010related serious adverse events and the median percent change in disabling seizure frequency from baseline at years 1, 2, and 3 of treatment and at the most recent follow\u2010up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>One hundred fifty patients met the criteria for analysis. The median reduction in seizures was 67% (interquartile range [IQR] = 33%\u201093%, n\u00a0=\u00a0149) at 1 year, 75% (IQR = 50%\u201094%, n\u00a0=\u00a093) at 2 years, 82% (IQR = 50%\u201096%, n\u00a0=\u00a038) at \u22653\u00a0years, and 74% (IQR = 50%\u201096%, n\u00a0=\u00a0150) at last follow\u2010up (mean\u00a0=\u00a02.3\u00a0years). Thirty\u2010five percent of patients had a \u226590% seizure frequency reduction, and 18% of patients reported being clinically seizure\u2010free at last follow\u2010up. Seizure frequency reductions were similar regardless of patient age, age at epilepsy onset, duration of epilepsy, seizure onset in mesial temporal or neocortical foci, magnetic resonance imaging findings, prior intracranial monitoring, prior epilepsy surgery, or prior vagus nerve stimulation treatment. The infection rate per procedure was 2.9% (6\/150 patients); five of the six patients had an implant site infection, and one had osteomyelitis. Lead revisions were required in 2.7% (4\/150), and 2.0% (3\/150) of patients had a subdural hemorrhage, none of which had long\u2010lasting neurological consequences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Significance<\/jats:title>\n                    <jats:p>In this real\u2010world experience, safety was similar and clinical seizure outcomes exceeded those of the prospective clinical trials, corroborating effectiveness of this therapy and suggesting that clinical experience has informed more effective programming.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/epi.16593","type":"journal-article","created":{"date-parts":[[2020,7,13]],"date-time":"2020-07-13T08:50:51Z","timestamp":1594630251000},"page":"1749-1757","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":132,"title":["Real\u2010world experience with direct brain\u2010responsive neurostimulation for focal onset seizures"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8623-8161","authenticated-orcid":false,"given":"Babak","family":"Razavi","sequence":"first","affiliation":[{"name":"Stanford University School of Medicine Stanford CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6389-2638","authenticated-orcid":false,"given":"Vikram R.","family":"Rao","sequence":"additional","affiliation":[{"name":"University of California San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Lin","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine Stanford CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1329-5085","authenticated-orcid":false,"given":"Krzysztof A.","family":"Bujarski","sequence":"additional","affiliation":[{"name":"Dartmouth Hitchcock Medical Center Lebanon NH USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjay E.","family":"Patra","sequence":"additional","affiliation":[{"name":"Spectrum Health Center Michigan State University School of Human Medicine East Lansing MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E.","family":"Burdette","sequence":"additional","affiliation":[{"name":"Spectrum Health Center Michigan State University School of Human Medicine East Lansing MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric B.","family":"Geller","sequence":"additional","affiliation":[{"name":"St. Barnabas Medical Center Livingston NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2470-3723","authenticated-orcid":false,"given":"Mesha\u2010Gay M.","family":"Brown","sequence":"additional","affiliation":[{"name":"University of Colorado Denver CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily A.","family":"Johnson","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine St. Louis MO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9977-983X","authenticated-orcid":false,"given":"Cornelia","family":"Drees","sequence":"additional","affiliation":[{"name":"University of Colorado Denver CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward F.","family":"Chang","sequence":"additional","affiliation":[{"name":"University of California San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet E.","family":"Greenwood","sequence":"additional","affiliation":[{"name":"Keck School of Medicine at University of Southern California Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christianne N.","family":"Heck","sequence":"additional","affiliation":[{"name":"Keck School of Medicine at University of Southern California Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara C.","family":"Jobst","sequence":"additional","affiliation":[{"name":"Dartmouth Hitchcock Medical Center Lebanon NH USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryder P.","family":"Gwinn","sequence":"additional","affiliation":[{"name":"Swedish Neuroscience Institute Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole M.","family":"Warner","sequence":"additional","affiliation":[{"name":"Swedish Neuroscience Institute Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3907-216X","authenticated-orcid":false,"given":"Casey H.","family":"Halpern","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine Stanford CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,7,13]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182302056"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12534"},{"key":"e_1_2_8_4_1","unstructured":"NairDR RNS System Investigators MorrellMJ et al.Nine\u2010Year Prospective Safety and Effectiveness Outcomes From the Long\u2010Term Treatment Trial of the RNS\u00ae System. 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