Transcutaneous supraorbital neurostimulation (tSNS).

In March of 2014, the Food and Drug Administration (FDA) approved the first medical device to be used for the prevention of migraine. This device is a 2 AAA battery-powered electrical stimulator applied to the forehead using a headband-like device manufactured by the Cefaly Technology Company of Herstal, Belgium intended for individuals with episodic migraine with or without aura, who have 2–8 attacks per month. A self-adhesive electrode pad is positioned over the center of the forehead, and the portable device is held in place with a plastic headband that rests on top of the ears (see Fig. 1). The device activates a low level electrical current intended to stimulate the upper branches of the trigeminal nerve which transmits some of the pain associated with migraines. In the United States, this device has one 60 hertz (Hz) setting and is to be used once per day for 20 minutes. The intensity increases to its maximum slowly, but may be maintained at a lower level with a single push of the button. Two pushes turns the device off. It is approved for patients 18 years and older, and is contraindicated in those with other implanted electrical devices such as pacemakers. In Europe and Canada, the device made by the same manufacturer has 3 stimulation settings: program 1 for acute “crisis treatment,” program 2 with 60 Hz for migraine prevention, and program 3 used for stress reduction and relaxation. FDA approval was based upon 2 studies conducted in Europe. The first was performed in Belgium, using 67 individuals who had at least 2 migraine attacks per month and had not taken any migraine preventive medications for 3 months prior to the study. Patients who were overusing medications, had failed 3 other sound preventive trials, had frequent tension-type headaches, as well as patients who had severe neurologic or psychiatric disorders, were all excluded from the trial. As a double blind trial, patients with similar characteristics were randomly divided into 2 groups. Both groups were given the device, and everyone received some degree of electrical stimulation, but only half of them got the same degree and type of stimulation offered by the Cefaly NeuroStimulation (tSNS) device. A 30-day baseline record was obtained during which no preventive treatment was used, and headache data were gathered, followed by 3 months in which the actual device or the sham device was used depending upon the assigned group. The 2 primary outcomes compared baseline with the third treated month, looking for: