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 Selleck JNK inhibitor 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 Selleck Apoptosis Compound Library sham OSBPL9 device was used depending upon the assigned group. The 2 primary outcomes compared baseline with the third treated month, looking for: A change in monthly migraine days. The percentage of subjects who had at least a 50% reduction in monthly migraine days. The first outcome measure, change in the number of migraine days, showed improvement, but not sufficient change to be considered significant. The second outcome, that is the percentage of those having at least a 50% reduction, was positive, meaning that if individuals did respond to the device,

they had a significant decrease in the number of headache days, seen in about 26% of subjects. Almost a third of subjects who did respond experienced a 25% reduction in headache days. The investigators also studied attack frequency, mean headache severity per migraine day, monthly intake of acute, as-needed medications, occurrence of migraine-associated symptoms per migraine day (nausea, light, and noise sensitivity), and percentage of very or moderately satisfied patients. There was a slight decrease in mean headache severity if individuals followed the protocol, and a highly significant almost 75% decrease in monthly acute migraine medications taken. Patient satisfaction was rated as 70% with the actual device compared with 40% with the sham device. There was no change in nausea, light, and noise sensitivity.