{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,11]],"date-time":"2026-04-11T13:51:59Z","timestamp":1775915519030,"version":"3.50.1"},"reference-count":44,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,9,17]],"date-time":"2024-09-17T00:00:00Z","timestamp":1726531200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","award":["177445"],"award-info":[{"award-number":["177445"]}],"id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100012856","name":"Alberta Children's Hospital Research Institute","doi-asserted-by":"publisher","award":["10026667"],"award-info":[{"award-number":["10026667"]}],"id":[{"id":"10.13039\/100012856","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2025,6]]},"abstract":"Abstract<\/jats:title>\n \n Objective<\/jats:title>\n Using a double\u2010dummy pilot randomized controlled trial design, we aimed to determine the feasibility and acceptability of comparing remote electrical neuromodulation (REN) to typical care intravenous pharmacologic interventions for the treatment of children and adolescents visiting the emergency department (ED) with migraine, and to compare parallel\u2010group versus crossover trial designs.<\/jats:p>\n <\/jats:sec>\n \n Background<\/jats:title>\n There are limited data to guide the management of migraine in the ED. Children and adolescents are interested in neuromodulation, and specifically REN, for treatment in this setting, but there are no existing data on this approach.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We employed a double\u2010dummy, double\u2010blind, pilot randomized controlled trial that tested two designs in two phases: a parallel\u2010group design and a crossover design (ClinicalTrials.gov identifier: NCT05102591). The intervention arms consisted of: (i) active REN stimulation with matched normal saline placebo intravenously, and (ii) matched sham REN stimulation, intravenous metoclopramide (0.15\u2009mg\/kg, maximum 10\u2009mg), and intravenous ketorolac (0.5\u2009mg\/kg, maximum 30\u2009mg). Youth aged 8.0\u2013<18.0\u2009years visiting a Canadian tertiary care pediatric ED with migraine attacks as per criteria B\u2013E of the International Classification of Headache Disorders third edition were eligible. Primary outcomes were focused on trial feasibility and acceptability, and preliminary efficacy and safety data were also collected.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 34% (22\/65) of those who screened eligible were enrolled. Three participants (14%) withdrew prior to receiving any study interventions. In all, 10 participants were allocated to typical care, and nine to REN. All treated participants (19\/19) completed all assessments. Recruitment was higher during the parallel\u2010group phase: 1.1 participants\/month versus 0.6 participants\/month, and 36% (17\/47) versus 28% (five of 18) of screened eligible were enrolled in the parallel\u2010group and crossover phases, respectively. Participants reported positive impressions of REN use in the ED, e.g., higher mean (standard deviation [SD]) levels of interest in using REN only at 3.7\u2009(1.0) versus 2.8\u2009(1.0) in using intravenous interventions only for a future ED visit. Participants and clinical staff reported overall positive impressions regarding the study protocol. Employing an 11\u2010point pain numerical rating scale, the mean (SD) reduction in pain severity score was 2.1\u2009(1.3) and 2.9\u2009(2.9) from baseline to 1\u2009h, and 2.4\u2009(1.6) and 4.0\u2009(3.5) from baseline to 2\u2009h for REN and intravenous interventions, respectively. One participant in the typical care group and none in the REN group experienced adverse events.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n We demonstrated the feasibility and acceptability of our trial protocol and of using REN to treat youth presenting to the ED with migraine. The parallel\u2010group design generated a higher recruitment rate than the crossover design. Our preliminary efficacy and safety data suggest that REN could be non\u2010inferior to typical care, but we were not powered for these outcomes. Further research on REN's use in the ED setting is warranted.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/head.14838","type":"journal-article","created":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T02:49:49Z","timestamp":1726627789000},"page":"1015-1026","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Remote electrical neuromodulation to treat children and adolescents with migraine in the emergency department: A\u00a0randomized double\u2010dummy pilot trial"],"prefix":"10.1111","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2879-811X","authenticated-orcid":false,"given":"Serena Laura","family":"Orr","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Cumming School of Medicine University of Calgary Calgary Alberta Canada"},{"name":"Department of Community Health Sciences, Cumming School of Medicine University of Calgary Calgary Alberta Canada"},{"name":"Department of Clinical Neurosciences, Cumming School of Medicine University of Calgary Calgary Alberta Canada"},{"name":"Alberta Children's Hospital Research Institute Calgary Alberta Canada"},{"name":"Hotchkiss Brain Institute Calgary Alberta Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan","family":"Kuziek","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Cumming School of Medicine University of Calgary Calgary Alberta Canada"},{"name":"Alberta Children's Hospital Research Institute Calgary Alberta Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samina","family":"Ali","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Faculty of Medicine & Dentistry University of Alberta Edmonton Alberta Canada"},{"name":"Women and Children's Health Research Institute, Faculty of Medicine and Dentistry University of Alberta Edmonton Alberta Canada"},{"name":"Department of Emergency Medicine, Faculty of Medicine and Dentistry University of Alberta Edmonton Alberta Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eva","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Physics Carleton University Ottawa Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathryn A.","family":"Birnie","sequence":"additional","affiliation":[{"name":"Alberta Children's Hospital Research Institute Calgary Alberta Canada"},{"name":"Department of Psychology University of Calgary Calgary Alberta Canada"},{"name":"Department of Anesthesiology, Perioperative and Pain Medicine; Department of Community Health Sciences University of Calgary Calgary Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1598-7536","authenticated-orcid":false,"given":"Andrew D.","family":"Hershey","sequence":"additional","affiliation":[{"name":"Division of Neurology Cincinnati Children's Hospital Medical Center Cincinnati Ohio USA"},{"name":"Department of Pediatrics University of Cincinnati College of Medicine Cincinnati Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prachi","family":"Khanna","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Kirton","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Cumming School of Medicine University of Calgary Calgary Alberta Canada"},{"name":"Department of Clinical Neurosciences, Cumming School of Medicine University of Calgary Calgary Alberta Canada"},{"name":"Alberta Children's Hospital Research Institute Calgary Alberta Canada"},{"name":"Hotchkiss Brain Institute Calgary Alberta Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tolulope","family":"Sajobi","sequence":"additional","affiliation":[{"name":"Department of Community Health Sciences, Cumming School of Medicine University of Calgary Calgary Alberta Canada"},{"name":"Department of Clinical Neurosciences, Cumming School of Medicine University of Calgary Calgary Alberta Canada"},{"name":"Hotchkiss Brain Institute Calgary Alberta Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen B.","family":"Freedman","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Cumming School of Medicine University of Calgary Calgary Alberta Canada"},{"name":"Alberta Children's Hospital Research Institute Calgary Alberta Canada"},{"name":"Department of Emergency Medicine, Cumming School of Medicine University of Calgary Calgary Alberta Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,9,17]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"crossref","DOI":"10.1017\/9781316819388","volume-title":"Emergency Headache: Diagnosis and Management","author":"Orr SL","year":"2017"},{"issue":"6","key":"e_1_2_10_3_1","doi-asserted-by":"crossref","first-page":"e310","DOI":"10.1097\/PEC.0000000000001285","article-title":"Family perspectives on visiting the pediatric emergency department for migraine","volume":"36","author":"Orr SL","year":"2020","journal-title":"Pediatr Emerg Care"},{"issue":"9","key":"e_1_2_10_4_1","doi-asserted-by":"crossref","first-page":"1504","DOI":"10.1111\/head.13639","article-title":"Economic impact of headache and psychiatric comorbidities on healthcare expenditures among children in the United States: a retrospective cross\u2010sectional study","volume":"59","author":"Law EF","year":"2019","journal-title":"Headache"},{"key":"e_1_2_10_5_1","unstructured":"U.S. Census Bureau QuickFacts: United States [Internet]. 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