In early March 2014, the FDA approved for use a transcutaneous electrical nerve stimulation device for the prevention of migraine, known as Cefaly. Since the FDA approval, many news outlets have been reporting on the availability of the device and many patients have been inquiring about the efficacy of the device and whether it is right for them.
Understanding of the device and the studies done to obtain FDA approval might help patients and physicians decide if it right for them.
Although the FDA categorized the Cefaly as a transcutaneous electrical nerve stimulation (TENS) unit, it is more specifically an external trigeminal nerve stimulation (eTNS) unit. The premise of the Cefaly is similar to that of other neurostimulators being tested for migraine treatment. Since the trigeminal nerve is involved in migraine, it’s theorized that stimulation of it can help with migraine prevention. It should be noted that “regular” TENS units should not be used in place of the Cefaly.
The device is available by prescription only and at this point is an out of pocket expense for patients. The cost of the device is $299 and $25 for a set of 3 reusable electrodes (each electrode is intended to be used 20 times). The device looks like a headband that is worn across the forehead with an electrode contacting the forehead. The device is intended to be worn for a 20-minute session, once per day, every day as a preventive treatment.
The FDA approval was based upon two studies that showed safety and tolerability of the device, with the smaller of the two studies showing a modest benefit in the reduction of days per month with migraine and less migraine medication usage than those who were using the placebo device.
This study was small, including only 67 patients with an average of nearly seven migraine days per month. The study found a statistically significant difference between the active device and placebo device with patients using the active device seeing a reduction of migraine days per month from nearly seven days per month to just under five days per month.1
A larger survey study was conducted of 2,313 migraine patients who rented the device for a 40-day period. This study found that 54% of patients were satisfied with the device and willing to purchase it.2 In both studies, there were not any serious adverse events, and most adverse events were minor.
Where does Cefaly fit in for the management of migraine?
At this point, it is premature to make any definitive statements about the long-term and sustained effectiveness of the device. Additional studies would be beneficial to provide further information regarding exactly what patient demographics best responded, and if the response is short-lived or if there is a sustained benefit.
Since there are relatively few side effects or significant potential consequences, it may be a beneficial tool to have available for patients who are either hesitant to try other preventive treatments or patients who for other health reasons cannot use other preventive treatments.
Thus far, there has been a huge public awareness of the availability of this device and to me that is the most exciting aspect of the Cefaly FDA approval. This reaffirms the message to clinicians and researchers that patients with migraine are in need of additional treatment options and are quite receptive to new potential treatment options.
Celfay’s effectiveness will be only determined by time, but its potential lasting impact might be the generation of more discussion around migraine and leading to more investigation of other treatment modalities.
For more information:
- Cefaly Device Approved by the FDA for Migraine Treatment
- Cefaly for Migraine – Answering Your Questions, Sharing My Experience
Reviewed for accuracy by the American Migraine Foundation’s subject matter experts, headache specialists and medical advisers with deep knowledge and training in headache medicine. Click here to read about our editorial board members.