Event Abstract Back to Event Prevention of Migraine by supraorbital transcutaneous neurostimulation with the Cefaly® device: the PREMICE trial. Delphine Magis1, 2, Bart Vandersmissen3, Sandrine Jeangette4, Luc Herroelen5, Michel Vandenheede6 and Jean Schoenen1* 1 ULg, Neurology & GIGA Neurosciences, Belgium 2 CHR Citadelle, Belgium 3 Erasme Hospital, Neurology, Belgium 4 CHU Charleroi, Belgium 5 AZ Gasthuisberg. KUL, Belgium 6 CHC Espérance, Belgium Background: Subjects who have frequent migraine attacks (≥ 2 / month) are in need of a preventive anti-migraine treatment. Available preventive drugs have incomplete efficacy and/or unpleasant side effects. Transcutaneous supraorbital neurostimulation has shown encouraging results for migraine preventive in pilot studies and it has no side effects. Objectives: To assess efficacy and safety in migraine prevention of transcutaneous supraorbital neurostimulation with the Cefaly® device in a multicentre, double-blinded, randomized, sham-controlled trial. Methods: After a 1-month run-in period, eligible patients were randomized 1:1 to verum or sham stimulation, and applied the Cefaly® device daily for 20 minutes druing 3 months. Primary outcome measures were change in monthly migraine days between the run-in month and the 3rd month of treatment, and percentage of subjects having a ≥ 50% reduction of monthly migraine days between run-in and 3rd month of treatment (“50% responders”). Results: Sixty-seven patients were randomized and included in the intention-to-treat analysis. During the 3rd month of treatment the mean number of migraine days was significantly lower compared to run-in in the verum (from 6.94+3.04 to 4.88+3.46; p=0.023), but not in the sham group (from 6.54+2.61 to 6.22+2.99; p=0.608). At 3 months of treatment the 50% responder rate was significantly greater (p=0.023) in the verum (38,1%) than in the sham group (12,1%). Monthly migraine attacks (p=0.044), monthly headache days (p=0.041) and monthly acute anti-migraine drug intake (p=0.007) were also significantly reduced in the verum group compared to the sham group. No adverse event or side effect occurred in either group. Conclusion: Transcutaneous supraorbital neurostimulation with the Cefaly® device was safe and effective as a preventive therapy for migraine. The therapeutic gain (26%) is within the range of those reported for other preventive drug and non-drug anti-migraine treatments. Keywords: Migraine, preventive therapy, supraorbital, transcutaneous, neurostimulation Conference: Belgian Brain Council, Liège, Belgium, 27 Oct - 27 Oct, 2012. Presentation Type: Poster Presentation Topic: Higher Brain Functions in health and disease: cognition and memory Citation: Magis D, Vandersmissen B, Jeangette S, Herroelen L, Vandenheede M and Schoenen J (2012). Prevention of Migraine by supraorbital transcutaneous neurostimulation with the Cefaly® device: the PREMICE trial.. Conference Abstract: Belgian Brain Council. doi: 10.3389/conf.fnhum.2012.210.00124 Copyright: The abstracts in this collection have not been subject to any Frontiers peer review or checks, and are not endorsed by Frontiers. They are made available through the Frontiers publishing platform as a service to conference organizers and presenters. The copyright in the individual abstracts is owned by the author of each abstract or his/her employer unless otherwise stated. Each abstract, as well as the collection of abstracts, are published under a Creative Commons CC-BY 4.0 (attribution) licence (https://creativecommons.org/licenses/by/4.0/) and may thus be reproduced, translated, adapted and be the subject of derivative works provided the authors and Frontiers are attributed. For Frontiers’ terms and conditions please see https://www.frontiersin.org/legal/terms-and-conditions. Received: 10 Aug 2012; Published Online: 12 Sep 2012. * Correspondence: Prof. Jean Schoenen, ULg, Neurology & GIGA Neurosciences, LIEGE, 4000, Belgium, jschoenen@ulg.ac.be Login Required This action requires you to be registered with Frontiers and logged in. To register or login click here. Abstract Info Abstract The Authors in Frontiers Delphine Magis Bart Vandersmissen Sandrine Jeangette Luc Herroelen Michel Vandenheede Jean Schoenen Google Delphine Magis Bart Vandersmissen Sandrine Jeangette Luc Herroelen Michel Vandenheede Jean Schoenen Google Scholar Delphine Magis Bart Vandersmissen Sandrine Jeangette Luc Herroelen Michel Vandenheede Jean Schoenen PubMed Delphine Magis Bart Vandersmissen Sandrine Jeangette Luc Herroelen Michel Vandenheede Jean Schoenen Related Article in Frontiers Google Scholar PubMed Abstract Close Back to top Javascript is disabled. Please enable Javascript in your browser settings in order to see all the content on this page.