{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T15:35:16Z","timestamp":1787499316569,"version":"build-2736575974"},"reference-count":38,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,1,27]],"date-time":"2023-01-27T00:00:00Z","timestamp":1674777600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2023,3]]},"abstract":"Abstract<\/jats:title>\n \n Objective<\/jats:title>\n To assess the clinical efficacy of remote electrical neuromodulation (REN), used every other day, for the prevention of migraine.<\/jats:p>\n <\/jats:sec>\n \n Background<\/jats:title>\n Preventive treatment is key to managing migraine, but it is often underutilized. REN, a non\u2010pharmacological acute treatment for migraine, was evaluated as a method of migraine prevention in patients with episodic and chronic migraine.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We conducted a prospective, randomized, double\u2010blind, placebo\u2010controlled, multi\u2010center trial, with 1:1 ratio. The study consisted of a 4\u2010week baseline observation phase, and an 8\u2010week double\u2010blind intervention phase in which participants used either REN or a placebo stimulation every other day. Throughout the study, participants reported their symptoms daily, via an electronic diary.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Two hundred forty\u2010eight participants were randomized (128 active, 120 placebo), of which 179 qualified for the modified intention\u2010to\u2010treat (mITT) analysis (95 active; 84 placebo). REN was superior to placebo in the primary endpoint, change in mean number of migraine days per month from baseline, with mean reduction of 4.0\u2009\u00b1 SD of\u20094.0\u2009days (1.3\u2009\u00b1\u20094.0 in placebo, therapeutic gain\u00a0=\u00a02.7 [confidence interval \u22123.9 to \u22121.5],\n p<\/jats:italic>\n \u2009<\u20090.001). The significance was maintained when analyzing the episodic (\u22123.2\u2009\u00b1\u20093.4 vs. \u22121.0\u2009\u00b1\u20093.6,\n p<\/jats:italic>\n \u00a0=\u00a00.003) and chronic (\u22124.7\u2009\u00b1\u20094.4 vs. \u22121.6\u2009\u00b1\u20094.4,\n p<\/jats:italic>\n \u00a0=\u00a00.001) migraine subgroups separately. REN was also superior to placebo in reduction of moderate\/severe headache days (3.8\u2009\u00b1\u20093.9 vs. 2.2\u2009\u00b1\u20093.6,\n p<\/jats:italic>\n \u00a0=\u00a00.005), reduction of headache days of all severities (4.5\u2009\u00b1\u20094.1 vs. 1.8\u2009\u00b1\u20094.6,\n p<\/jats:italic>\n \u2009<\u20090.001), percentage of patients achieving 50% reduction in moderate\/severe headache days (51.6% [49\/95] vs. 35.7% [30\/84],\n p<\/jats:italic>\n \u00a0=\u00a00.033), and reduction in days of acute medication intake (3.5\u2009\u00b1\u20094.1 vs. 1.4\u2009\u00b1\u20094.3,\n p<\/jats:italic>\n \u00a0=\u00a00.001). Similar results were obtained in the ITT analysis. No serious device\u2010related adverse events were reported in any group.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Applied every other day, REN is effective and safe for the prevention of migraine.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/head.14469","type":"journal-article","created":{"date-parts":[[2023,1,27]],"date-time":"2023-01-27T04:21:25Z","timestamp":1674793285000},"page":"377-389","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":51,"title":["Remote electrical neuromodulation for migraine prevention: A double\u2010blind, randomized, placebo\u2010controlled clinical trial"],"prefix":"10.1111","volume":"63","author":[{"given":"Stewart J.","family":"Tepper","sequence":"first","affiliation":[{"name":"The Geisel School of Medicine at Dartmouth Hanover New Hampshire USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liron","family":"Rabany","sequence":"additional","affiliation":[{"name":"Theranica Bio\u2010Electronics Ltd. Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert P.","family":"Cowan","sequence":"additional","affiliation":[{"name":"Division of Headache Medicine Stanford University Palo Alto California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy R.","family":"Smith","sequence":"additional","affiliation":[{"name":"StudyMetrix Research St. Peters Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian M.","family":"Grosberg","sequence":"additional","affiliation":[{"name":"Hartford Healthcare Headache Center Hartford Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley D.","family":"Torphy","sequence":"additional","affiliation":[{"name":"Chicago Headache Center and Research Institute Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dagan","family":"Harris","sequence":"additional","affiliation":[{"name":"Theranica Bio\u2010Electronics Ltd. Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maya","family":"Vizel","sequence":"additional","affiliation":[{"name":"Theranica Bio\u2010Electronics Ltd. Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alon","family":"Ironi","sequence":"additional","affiliation":[{"name":"Theranica Bio\u2010Electronics Ltd. Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alit","family":"Stark\u2010Inbar","sequence":"additional","affiliation":[{"name":"Theranica Bio\u2010Electronics Ltd. Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew M.","family":"Blumenfeld","sequence":"additional","affiliation":[{"name":"The Los Angeles Headache Center Los Angeles California USA"},{"name":"San Diego Headache Center San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,1,27]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"crossref","first-page":"954","DOI":"10.1016\/S1474-4422(18)30322-3","article-title":"Global, regional, and national burden of migraine and tension\u2010type headache, 1990\u20132016: a systematic analysis for the global burden of disease study 2016","volume":"17","author":"Stovner LJ","year":"2018","journal-title":"Lancet Neurol"},{"key":"e_1_2_11_3_1","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1016\/j.nurpra.2022.01.018","article-title":"Migraine in adult primary care","volume":"18","author":"Wilbanks 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