A profile on the Cefaly dual trigeminal neurostimulator for acute and preventive migraine treatment: an overview of its safety and efficacy

INTRODUCTION: Migraine is one of the leading causes of disability worldwide. Neuromodulation is a non-pharmacologic class of treatment for migraine. Cefaly is a neuromodulatory device that modulates pain through peripheral nerve stimulation of the supraorbital and supratrochlear nerves, leading to central pain modulation through the trigeminal nucleus caudalis (TNC). AREAS COVERED: This review article discusses the physiology of migraine with reference to neuromodulation, summarizes the available evidence for the use of Cefaly in acute and preventive treatment of migraine, including studies that led to its clearance by the Food and Drug Administration (FDA) and clinical trials ongoing at the time of this publication. We also review potential side effects and contraindications for using the device. Additionally, this article contrasts Cefaly with other available neuromodulation devices for management of migraine. EXPERT OPINION: Cefaly is a well-tolerated, non-pharmacologic treatment option for both acute and preventive management of migraine. The available evidence, while moderate in quality, demonstrates efficacy in reducing migraine frequency, migraine attack pain relief, and acute medication use across diverse populations. Its favorable safety profile makes it a particularly feasible and valuable options for patients who have comorbid medical conditions, polypharmacy, or who prefer a non-drug option to care.