Migraine sufferers will be glad to know that the FDA has recently approved the first device for preventing migraine headaches.
Cefaly is a band-like device that delivers electrical stimulation (also known as TENS) to the forehead, near the trigeminal nerve, which runs under the skin and covers much of the face, and which has been implicated in some migraines. It is applied daily for 20 minutes to prevent headaches. It does not stop headaches once they have started.
Who should consider Cefaly for migraine?
1) People who have frequent, disabling migraines. “Frequent” means 2 or more headaches a month.
2) People who can’t get relief from abortive medication. This means that when you have a headache the medications you have tried either don’t stop the headache or cause intolerable side effects. This group of people would also include patients who cannot take certain medications because of vomiting (pills) or skin disease (patches).
3) People who do not want to take medication to prevent their migraines.
How Cefaly compares to other preventive therapies
In the study which resulted in FDA approval, 67 patients used the device for 3 months. The number needed to treat to get 50% response was similar to that of other treatments used to prevent migraines. The study also demonstrated fewer migraines and less of a need to take abortive medications.
53% of patients in another study were willing to buy the device to continue treatment.
Cefaly is expensive compared to other therapies because it involves a large initial outlay for the device ($295) and electrodes ($25). In some countries, the device has been available as a rental.
Certain effective preventive therapies for migraine are available as generics. However, prescription medications require a prescription, which typically means a doctor’s office visit. Some medications for migraine prevention in patients for whom propranolol and amitryptiline are not options are very expensive.
Two herbal preparations (butterbur and feverfew) and melatonin (a hormone) are available over the counter. Butterbur is not found in most pharmacies, however, and most patients might have to order it online.
Short term side effects include sleepiness, intolerance to the electrical sensation of the device, headache, and skin allergy. Side effects affect 4.3% of users, which is a very low number compared to oral medication. Long term side effects have not been assessed formally. However, implanted neural stimulation in the area of the head has been used for 20 years without long term effects due to the stimulation. This is why the FDA allowed Cefaly, an external stimulator, to be evaluated as a “low risk” device.
Use in special populations
Cefaly is not yet approved for use in pregnant women or children.
Cefaly Technology. “Cefaly Migraine.” Migraine Prevention Cefaly. Cefaly Technology, 2014. Web. 18 Mar. 2014.
Modi, Seema, and Dionne M. Louder. “Medications for Migraine Prophylaxis.” American Family Physician 73.1 (2006): 72-78. Print.