{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T14:13:58Z","timestamp":1790604838270,"version":"4.1.0"},"reference-count":27,"publisher":"SAGE Publications","issue":"11-12","license":[{"start":{"date-parts":[[2021,5,14]],"date-time":"2021-05-14T00:00:00Z","timestamp":1620950400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Although the European Medicines Agency and the US Food and Drug Administration have cleared several devices that use neuromodulation to provide clinical benefits in the acute or preventive treatment of migraine, the Clinical Trials Committee of the International Headache Society has not developed guidelines specifically for clinical trials of neuromodulation devices. In recognition of the distinct needs and challenges associated with their assessment in controlled trials, the Committee provides these recommendations for optimizing the design and conduct of controlled trials of neuromodulation devices for the acute and\/or preventive treatment of migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>An international group of headache scientists and clinicians with expertise in neuromodulation evaluated clinical trials involving neuromodulation devices that have been published since 2000. The Clinical Trials Committee incorporated findings from this expert analysis into a new guideline for clinical trials of neuromodulation devices for the treatment of migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Key terms were defined and recommendations provided relative to the assessment of neuromodulation devices for acute treatment in adults, preventive treatment in adults, and acute and preventive treatment in children and adolescents. Ethical and administrative responsibilities were outlined, and a bibliography of previous research involving neuromodulation devices was created.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Adoption of these recommendations will improve the quality of evidence regarding this important area in migraine treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024211010413","type":"journal-article","created":{"date-parts":[[2021,5,14]],"date-time":"2021-05-14T22:06:31Z","timestamp":1621029991000},"page":"1135-1151","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":33,"title":["Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine"],"prefix":"10.1177","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1513-2113","authenticated-orcid":false,"given":"Cristina","family":"Tassorelli","sequence":"first","affiliation":[{"name":"Headache Science & Neurorehabilitation Centre, IRCCS C. Mondino Foundation, Pavia, Italy"},{"name":"Department of Brain and Behavioral Sciences, University of Pavia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6556-8612","authenticated-orcid":false,"given":"Hans-Christoph","family":"Diener","sequence":"additional","affiliation":[{"name":"Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9467-5567","authenticated-orcid":false,"given":"Stephen D","family":"Silberstein","sequence":"additional","affiliation":[{"name":"Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David W","family":"Dodick","sequence":"additional","affiliation":[{"name":"Department of Neurology, Mayo Clinic, Phoenix, AZ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3260-5904","authenticated-orcid":false,"given":"Peter J","family":"Goadsby","sequence":"additional","affiliation":[{"name":"National Institute for Health Research-Wellcome Trust King\u2019s Clinical Research Facility, King\u2019s College London, UK"},{"name":"Department of Neurology, University of California, Los Angeles, Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rigmor H","family":"Jensen","sequence":"additional","affiliation":[{"name":"Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4392-9413","authenticated-orcid":false,"given":"Delphine","family":"Magis","sequence":"additional","affiliation":[{"name":"Headache and Pain Clinic, CHR East Belgium, 4800 Verviers, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Pozo-Rosich","sequence":"additional","affiliation":[{"name":"Headache Unit, Neurology Department, Vall d\u2019Hebron University Hospital & Headache Research Group, Vall d\u2019Hebron Research Institute, Universitat Autonoma de Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hsiangkuo","family":"Yuan","sequence":"additional","affiliation":[{"name":"Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6355-7947","authenticated-orcid":false,"given":"Daniele","family":"Martinelli","sequence":"additional","affiliation":[{"name":"Headache Science & Neurorehabilitation Centre, IRCCS C. Mondino Foundation, Pavia, Italy"},{"name":"Department of Brain and Behavioral Sciences, University of Pavia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas van den","family":"Hoek","sequence":"additional","affiliation":[{"name":"Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7818-9841","authenticated-orcid":false,"given":"Marie","family":"Deen","sequence":"additional","affiliation":[{"name":"Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Messoud","family":"Ashina","sequence":"additional","affiliation":[{"name":"Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gisela M","family":"Terwindt","sequence":"additional","affiliation":[{"name":"Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,5,14]]},"reference":[{"key":"bibr1-03331024211010413","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419828967"},{"key":"bibr2-03331024211010413","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418758283"},{"key":"bibr3-03331024211010413","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420941839"},{"key":"bibr4-03331024211010413","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419842188"},{"key":"bibr5-03331024211010413","unstructured":"Regulation (Eu) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC. 2020. https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02017R0745-20200424 (accessed 25 January 2021)."},{"key":"bibr6-03331024211010413","unstructured":"US Food and Drug Administration. 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