This FDA-approved treatment for migraine is a welcome alternative for patients who have significant medication intolerances or who wish to try a non-pharmacologic approach to treatment.
The Cefaly device is a transcutaneous supraorbital neurostimulation device recently FDA-approved for the prevention of episodic migraine. It is described as a futuristic-appearing silver headband that is worn over the forehead and generates stimulation to the supratrochlear and supraorbital branches of the first division of the trigeminal nerve (Figure). The device is programmed to run for a 20-minute session once activated: during that time it delivers increasingly strong biphasic electrical impulses.
In the United States the device is meant to be used daily in the prevention of episodic migraine; however, European versions of the device include “acute treatment” and “relaxation” settings that have not been reviewed in an available published study.
The device was validated in a double-blinded, randomized, sham-controlled trial of 67 subjects with episodic migraine (the PREMICE study) published in Neurology in 2013.1 The study included adult patients who met ICHD-II criteria for episodic migraine, with or without aura, who experienced at least 2 migraines per month and who were not taking a preventative medication. Patients were excluded if they failed more than 3 migraine preventatives or also had the diagnosis of medication overuse headache. Subjects were randomized to either sham or treatment arms, and received treatment for 20 minutes daily. They were followed for 3 months.
In the treatment group, there was a trend toward a decrease in migraine frequency by the third month of treatment: 38% of those in this group had a greater than 50% reduction in migraine days compared to 12% in the sham group. There was no difference in migraine severity between the two groups. There was also no difference in outcomes between subjects who had migraine with or without aura.
While there were no significant adverse events during this trial, compliance was somewhat poor. The treatment group used the device on average only 62% of the time recommended, which was statistically similar to the sham group. The authors speculated the compliance issues were due to the relatively long 20-minute duration of each treatment session, rather than to any intolerances to the device. Overall the study demonstrated moderate, Class III level, evidence for the device for episodic migraine prevention.
The initial efficacy study was followed by a published survey of 2313 users of the Cefaly device in Europe to determine safety and tolerability.2 This survey found that the Cefaly was considered safe: only 4.3% of patients noted adverse events, none serious. The most common side effects were paresthesias to the area of stimulation and fatigue. The most serious adverse effect was a local skin reaction, presumed to be a response to the acrylate in the adhesive, and was seen in 2 subjects. After the 40-day trial, 54.4% of patients noted they were satisfied and would be willing to purchase the device for continued use.
In clinical practice, the Cefaly device can be considered a low risk preventative option that may reduce headache frequency in about half of patients with episodic migraine. While the available clinical data regarding its efficacy are modest, this may be in part to due to limited sample size in the initial clinical trial, poor adherence, and the current lack of additional confirmatory studies. It remains to be seen whether device is more helpful if used as an adjunct to preventative medications or other therapies, or if there are particular migraine subtypes in which the device may be particularly beneficial.
Given that it is an FDA-approved treatment for migraine, however, the Cefaly device has very little potential downside when compared with the side effect profile of many existing migraine medications. This is a welcome alternative for the many patients with migraine who have significant medication intolerances or who wish to try a non-pharmacologic approach to treatment.
The Cefaly device is currently available with a prescription through the company’s US website.
1. Schoenen J, Vandersmissen B, Jeangette S, et al. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial.Neurology. 2013;80:697-704.
2. Magis D, Sava S, Sasso d’Elia T, et al. Safety and patients’ satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly device in headache treatment: a survey of 2,313 headache sufferers in the general population.J Headache Pain. 2013;14:95.