Authors' objectives: To determine whether there is any evidence on the efficacy/effectiveness of external trigeminal nerve stimulation, c.q. Cefaly®, in treating and preventing migraine headaches.

Authors' results and conclusions: The literature search was limited to those classified as “randomized/controlled trial” only and 31 published studies were identified in this systematic search. Upon examination of the titles and abstracts of these 31 articles, 16 published studies were thought to be relevant and were retrieved in full for further appraisal. No further relevant primary studies were identified from manual searches. Of the 16 studies that were retrieved in full, three studies were not relevant to the objective of this systematic review and will not be discussed further. At the same time, multiple publications of the TEAM trial and the PREMICE study was identified. Since, many of these duplicate publications were published in an abstract only format, we excluded these studies and only presented those published in full. Hence, a total of six published studies is presented in this systematic review. At present, there are some high-level low quality as well as low level low quality, evidence on the efficacy/effectiveness of the Cefaly® device to prevent and treat migraine headaches. This available evidence must be interpreted with caution as the potential effect of bias, chance and confounding cannot be excluded from the available data. Furthermore, a potential conflict of interest was also observed from the published studies.

Authors' methods: A comprehensive and systematic literature search was conducted on July 10, 2025. The search was done on commercial medical literature databases where a combination of key words was employed in this search. No limitation, such as on the language or date of publication, was implemented in any of these searches. A manual search, on the references for the article retrieved in full, was planned.

Project Status: Completed

URL for project: https://www.worksafebc.com/en/about-us/research-services/evidence-based-medicine-and-systematic-reviews

Year Published: 2025

URL for published report: https://www.worksafebc.com/en/resources/health-care-providers/guides/external-trigeminal-nerve-stimulation?lang=en&origin=s&returnurl=https%3A%2F%2Fwww.worksafebc.com%2Fen%2Fforms-resources%23sort%3DDate%26q%3DExternal%2520Trigeminal%2520Nerve%2520Stimulation%2520(e-TNS)%2520in%2520Treating%2520and%2520Preventing%2520Migraine%2520Headaches%26f%3Alanguage-facet%3D%5BEnglish%5D%26tags%3DHealth%2520Care%2520Provider%7C13468b0b3f074f6bade3f57ac3cdfb8e%2CSystematic%2520Review%7Cf78c29d570c14ec3b5a394385905df70&highlight=External%20Trigeminal%20Nerve%20Stimulation%20(e-TNS)%20in%20Treating%20and%20Preventing%20Migraine%20Headaches

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Canada

Organisation Name: WorkSafeBC

Contact Address: 6591 Westminster Highway, Richmond, BC, V7C 1C6 Canada. Tel: 604-231-8417; Fax: 604-279-7698

Contact Name: ebpg@worksafebc.com

Contact Email: ebpg@worksafebc.com

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