Table of ContentsView AllTable of ContentsHow Cefaly WorksHow to Use ItUse for PreventionUse for AttacksSide EffectsContraindicationsFrequently Asked Questions
Table of ContentsView All
View All
Table of Contents
How Cefaly Works
How to Use It
Use for Prevention
Use for Attacks
Side Effects
Contraindications
Frequently Asked Questions
Verywell / Cindy Chung
This current stimulates a branch of the trigeminal nerve. This cranial nerve controls the sensation of the face and it is believed to play a role in migraines. The electrical current doesn’t directly reach the whole trigeminal nerve, however. Rather, it reaches the supratrochlear and supraorbital branches of the ophthalmic nerve, a branch of the trigeminal nerve.
The Anatomy of the Cranial Nerves
According to its manufacturers, the electrical current of the Cefaly device gradually increases in intensity during the first 14 minutes of use.If you feel that the current is becoming too intense for you, you can press a button to stabilize the intensity and halt any further increase in intensity.
The Cefaly device has two settings: one for migraine prevention and one for use during an acute migraine.
Use for Migraine Prevention
Migraine preventionrelies on taking prescription medication on a daily basis. Like medications used for migraine prevention, Cefaly can be used every day.
The FDA approval for Cefaly as a prophylactic treatment was based on the results of two European trials: the PREMICE Trial and the European Post-Marketing Surveillance Study.
The PREMICE Trial
This study included 67 participants who had at least two migraine attacks each month prior to the study. Some participants received Cefaly treatment and some received asham, or placebo, treatment. The treatment period for each participant lasted for three months.
Here are the results of the study:
The European Post-Marketing Surveillance Study
A registry was established for all of the people who obtained the Cefaly device between September 2009 and June 2012, most of whom lived in France and Belgium. After having used the device for between 40 and 80 days, they were asked to participate in a survey assessing satisfaction and concerns about negative side effects.
The results of this post-marketing study showed that about 53% of those who used the device were satisfied with the treatment and wanted to continue using it, while about 4% were dissatisfied with the device. None of the complaints involved serious adverse effects.
Use for Migraine Attacks
After the device had already been approved for migraine prevention, the FDA also approved Cefaly for the treatment of acute migraine attacks.
An open-label trial examining the safety and efficacy of Cefaly for the treatment of an acute migraine was published in the journalNeuromodulationin October 2017.
The study included 30 participants who were experiencing migraines for at least three hours and had not taken any medication during the migraine attack. Treatment with Cefaly was given for one hour.
The researchers did not report any adverse events or participant complaints about the treatment.
A small percentage of patients have reported minor side effects when using Cefaly. Possible side effects include:
The manufacturer does list contraindications that you should be aware of. You cannot use Cefaly if you have:
Experts aren’t sure if Cefaly is safe during pregnancy, so if you use this device, be sure to tell your healthcare provider if you are pregnant or planning on becoming pregnant.
A Word From Verywell
Unlike medications, however, Cefaly has not been reported to have any serious adverse effects, which can be an advantage if you experience side effects from your migraine medications.
Side effects of Cefaly can include tingling skin, sleepiness during usage, headache after usage, and skin irritation. It is considered very safe for most people.
Neurostimulation Devices for Migraines
12 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S. Food and Drug Administration.Letter to Cefaly Technology re: K201895, regulation number: 21 CFR 882.5891.Cefaly website.How Cefaly Works.American Migraine Foundation.Cefaly for Migraine Prevention.Westwood SJ, Conti AA, Tang W, Xue S, Cortese S, Rubia K.Clinical and cognitive effects of external trigeminal nerve stimulation (eTNS) in neurological and psychiatric disorders: a systematic review and meta-analysis.Mol Psychiatry. Published online September 6, 2023. doi:10.1038/s41380-023-02227-4Riederer F, Penning S, Schoenen J.Transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly® Device for Migraine Prevention: A review of the available data.Pain Ther4, 135–147 (2015). doi:10.1007/s40122-015-0039-5U.S. Food and Drug Administration. Regulatory Information.De Novo Classification Request for Cefaly Device.Department of Health and Human Services.Letter to Cefaly Technology re: K171446, regulation number 21 CFR 882.58.91.Chou DE, Gross GJ, Casadei C, Yugrakh MS.External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open‐Label Trial on Safety and Efficacy.Neuromodulation. 05 June 2017. doi:10.1111/ner.12623Danno D, Iigaya M, Imai N, et al.The safety and preventive effects of a supraorbital transcutaneous stimulator in Japanese migraine patients.Sci Rep9, 9900. doi:10.1038/s41598-019-46044-8Cefaly website.FAQs.American Migraine Foundation.Neuromodulation For Migraine Prevention.U.S. Food and Drug Administration.Treating Migraines: More Ways to Fight the Pain.
12 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S. Food and Drug Administration.Letter to Cefaly Technology re: K201895, regulation number: 21 CFR 882.5891.Cefaly website.How Cefaly Works.American Migraine Foundation.Cefaly for Migraine Prevention.Westwood SJ, Conti AA, Tang W, Xue S, Cortese S, Rubia K.Clinical and cognitive effects of external trigeminal nerve stimulation (eTNS) in neurological and psychiatric disorders: a systematic review and meta-analysis.Mol Psychiatry. Published online September 6, 2023. doi:10.1038/s41380-023-02227-4Riederer F, Penning S, Schoenen J.Transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly® Device for Migraine Prevention: A review of the available data.Pain Ther4, 135–147 (2015). doi:10.1007/s40122-015-0039-5U.S. Food and Drug Administration. Regulatory Information.De Novo Classification Request for Cefaly Device.Department of Health and Human Services.Letter to Cefaly Technology re: K171446, regulation number 21 CFR 882.58.91.Chou DE, Gross GJ, Casadei C, Yugrakh MS.External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open‐Label Trial on Safety and Efficacy.Neuromodulation. 05 June 2017. doi:10.1111/ner.12623Danno D, Iigaya M, Imai N, et al.The safety and preventive effects of a supraorbital transcutaneous stimulator in Japanese migraine patients.Sci Rep9, 9900. doi:10.1038/s41598-019-46044-8Cefaly website.FAQs.American Migraine Foundation.Neuromodulation For Migraine Prevention.U.S. Food and Drug Administration.Treating Migraines: More Ways to Fight the Pain.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
U.S. Food and Drug Administration.Letter to Cefaly Technology re: K201895, regulation number: 21 CFR 882.5891.Cefaly website.How Cefaly Works.American Migraine Foundation.Cefaly for Migraine Prevention.Westwood SJ, Conti AA, Tang W, Xue S, Cortese S, Rubia K.Clinical and cognitive effects of external trigeminal nerve stimulation (eTNS) in neurological and psychiatric disorders: a systematic review and meta-analysis.Mol Psychiatry. Published online September 6, 2023. doi:10.1038/s41380-023-02227-4Riederer F, Penning S, Schoenen J.Transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly® Device for Migraine Prevention: A review of the available data.Pain Ther4, 135–147 (2015). doi:10.1007/s40122-015-0039-5U.S. Food and Drug Administration. Regulatory Information.De Novo Classification Request for Cefaly Device.Department of Health and Human Services.Letter to Cefaly Technology re: K171446, regulation number 21 CFR 882.58.91.Chou DE, Gross GJ, Casadei C, Yugrakh MS.External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open‐Label Trial on Safety and Efficacy.Neuromodulation. 05 June 2017. doi:10.1111/ner.12623Danno D, Iigaya M, Imai N, et al.The safety and preventive effects of a supraorbital transcutaneous stimulator in Japanese migraine patients.Sci Rep9, 9900. doi:10.1038/s41598-019-46044-8Cefaly website.FAQs.American Migraine Foundation.Neuromodulation For Migraine Prevention.U.S. Food and Drug Administration.Treating Migraines: More Ways to Fight the Pain.
U.S. Food and Drug Administration.Letter to Cefaly Technology re: K201895, regulation number: 21 CFR 882.5891.
Cefaly website.How Cefaly Works.
American Migraine Foundation.Cefaly for Migraine Prevention.
Westwood SJ, Conti AA, Tang W, Xue S, Cortese S, Rubia K.Clinical and cognitive effects of external trigeminal nerve stimulation (eTNS) in neurological and psychiatric disorders: a systematic review and meta-analysis.Mol Psychiatry. Published online September 6, 2023. doi:10.1038/s41380-023-02227-4
Riederer F, Penning S, Schoenen J.Transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly® Device for Migraine Prevention: A review of the available data.Pain Ther4, 135–147 (2015). doi:10.1007/s40122-015-0039-5
U.S. Food and Drug Administration. Regulatory Information.De Novo Classification Request for Cefaly Device.
Department of Health and Human Services.Letter to Cefaly Technology re: K171446, regulation number 21 CFR 882.58.91.
Chou DE, Gross GJ, Casadei C, Yugrakh MS.External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open‐Label Trial on Safety and Efficacy.Neuromodulation. 05 June 2017. doi:10.1111/ner.12623
Danno D, Iigaya M, Imai N, et al.The safety and preventive effects of a supraorbital transcutaneous stimulator in Japanese migraine patients.Sci Rep9, 9900. doi:10.1038/s41598-019-46044-8
Cefaly website.FAQs.
American Migraine Foundation.Neuromodulation For Migraine Prevention.
U.S. Food and Drug Administration.Treating Migraines: More Ways to Fight the Pain.
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