{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T07:07:44Z","timestamp":1774940864418,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/f1000research.149807.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,8,29]],"date-time":"2025-08-29T00:00:00Z","timestamp":1756425600000}}],"reference-count":20,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2025,8,29]],"date-time":"2025-08-29T00:00:00Z","timestamp":1756425600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100013297","name":"Eurostars.  The Eurostars Program is a joint initiative of EUREKA and the European Community.","doi-asserted-by":"publisher","award":["(E!115549\u2013CEREBRI)"],"award-info":[{"award-number":["(E!115549\u2013CEREBRI)"]}],"id":[{"id":"10.13039\/100013297","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Oslo Regional Research Fund"}],"content-domain":{"domain":["f1000research.com"],"crossmark-restriction":false},"short-container-title":["F1000Res"],"abstract":"<ns3:p>Introduction Biofeedback is a non-pharmacological treatment option valued for its minimal risk of adverse events and offers a safe alternative for individuals seeking preventive care for migraine. Despite level A evidence for migraine prevention, biofeedback treatment is still unavailable to most patients. We developed a novel medical device (Cerebri) for multimodal biofeedback treatment that omits the need for healthcare personnel involvement. Cerebri consists of a smartphone application (app) and two wireless sensors. Unique in its approach, the Cerebri app seamlessly integrates three biofeedback modalities \u2013 heart rate variability, temperature, and electromyography \u2013 making it a comprehensive, therapist-independent solution for non-pharmacological migraine management. Methods Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (The BioCer study) is an open-label, randomized, waitlist-controlled, multicenter trial. This study investigates the safety and efficacy of daily home-based biofeedback sessions using the Cerebri device. A total of 286 participants will be randomized to either a 12-week intervention arm or waitlist control arm. The primary outcome is the change in the mean number of migraine days from baseline to the last 28-day period during the treatment phase in the treatment group compared with the control group. The primary outcome variable is prospectively collected through daily eDiary entries. A limitation is the inability to conduct a sham-controlled trial of biofeedback. Ethics and Dissemination Approval from the ethics committee and competent authorities was obtained prior to study initiation. Participation is voluntary and informed and written consent is obtained prior to inclusion. The results of this trial will be published in peer-reviewed international medical journals and communicated to patients and healthcare personnel through the relevant channels. Trial registration numbers EUDAMED: CIV-NO-22-08-040446 REK (Regional Committees for Medical and Health Research Ethics): 502734 Date of approval 2022-10-14 Trial registration: NCT05616741, 2022-11-15, https:\/\/clinicaltrials.gov\/study\/NCT05616741<\/ns3:p>","DOI":"10.12688\/f1000research.149807.2","type":"journal-article","created":{"date-parts":[[2025,8,29]],"date-time":"2025-08-29T16:00:07Z","timestamp":1756483207000},"page":"775","update-policy":"https:\/\/doi.org\/10.12688\/f1000research.crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (BioCer): a randomized, wait-list controlled trial \u2013 the study protocol"],"prefix":"10.12688","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-6747-6475","authenticated-orcid":false,"given":"Amalie Christine","family":"Poole","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anker","family":"Stubberud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2763-6343","authenticated-orcid":false,"given":"Melanie","family":"Simpson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lise","family":"\u00d8ie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8361-7005","authenticated-orcid":false,"given":"Einar Tobias Vassb\u00f8","family":"Skalstad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5745-1094","authenticated-orcid":false,"given":"Marte-Helene","family":"Bj\u00f8rk","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8999-5424","authenticated-orcid":false,"given":"Espen Saxhaug","family":"Kristoffersen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kjersti Gr\u00f8tta","family":"Vetvik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8691-3860","authenticated-orcid":false,"given":"Alexander","family":"Olsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iben Cornelia Keim","family":"Larsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mattias","family":"Linde","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erling Andreas","family":"Tronvik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2295-123X","authenticated-orcid":false,"given":"Tore Wergeland","family":"Meisingset","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2025,8,29]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"105-125","DOI":"10.1007\/978-3-030-24728-7_9","author":"L Stovner","journal-title":"Societal Impact of Headache: Burden, Costs and Response."},{"key":"ref2","doi-asserted-by":"publisher","first-page":"703-711","DOI":"10.1111\/j.1468-1331.2011.03612.x","article-title":"The cost of headache disorders in Europe: the Eurolight project.","volume":"19","author":"M Linde","year":"2012","journal-title":"Eur. 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The Eurostars Program is a joint initiative of EUREKA and the European Community. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":2,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}