The trial was set up to capture changes in migraines after 3 months totaling 90 daily sessions of 20 minutes each. However, 1 problem in determining the effectiveness of this device is that subjects in the actual trial failed to turn it on reliably and daily. Overall, participants only did an average of 56 sessions in 3 months. One can see where the commitment of 20 minutes each and every day
for 3 months can be difficult in busy lives, although the device is battery powered, and wearers can do their usual activities while it is operating. By comparison, this device appears not to match the preventive benefits seen with topiramate, another FDA-approved migraine medicine. Topiramate can click here decrease the number of migraine days by 44% as opposed to this device, use of which resulted in a 25% reduction of days. The number of migraine attacks with topiramate was reduced by 48%, while the device reduced NVP-BGJ398 clinical trial the attack number by 19%. However, the side effects from topiramate can be very problematic, and result in many patients abandoning the medication because of memory problems,
numbness and tingling, or kidney stones. Side effects of the device occurred in less than 5% of individuals, and were mild and temporary, with irritation or pain at the site of the electrode pads, tension headache, or mild drowsiness being most common. Some sleepiness or fatigue was reported in fewer than 1% of subjects, but that effect may have been incorporated into the stress reduction and relaxation program built into the program 3 setting of the European model. A much larger follow-up study was performed to gauge safety and satisfaction in users of this supraorbital neurostimulation device, obtained from 2313 subjects who rented the device for a 40-day trial
period through the internet. Satisfaction was found in 53.4% of subjects, and they were willing to purchase the device, while 46.6% of the subjects were not satisfied and returned it. The returned devices were downloaded, and it was found that the users only had them turned on 48.6% of the required daily selleckchem time. As of now, in the United States, the device is not generally covered by insurance, and costs about $299 plus $35 for shipping. A prescription must accompany each order. A 3 pack of electrodes is $25, with an additional $5 for shipping. Each electrode pad lasts between 15 and 30 sessions. The company does not accept credit cards, and only accepts payment through PayPal as of June 2014. Some patients have been able to get insurance reimbursement if transcutaneous electrical stimulation devices units are covered on their plan. There is not yet a US billable code specific to this device, and the company has said that patients must seek this reimbursement from the insurance company on their own.