The Food and Drug Administration has approved the marketing of the first neurostimulation device to prevent migraine headaches.
The Cefaly stimulator, which looks like a space age tiara, is a battery-powered device worn over the forehead like a headband. It delivers transcutaneous supraorbital nerve stimulation through an electrode to the nerve endings of the trigeminal nerve, which has been associated with migraine headaches.
Users may feel a tingling or massaging sensation where the electrode is applied.
A recent study on 67 migraine patients found that wearing the Cefaly device for 20 minutes a day reduced the number of migraines just as effectively as migraine drugs or other types of migraine therapy. The patients’ use of migraine drugs also declined significantly.
“Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health.
“This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”
The FDA cautioned the device does not completely prevent migraines and does not reduce their intensity.
“The use of the Cefaly device as preventive therapy for migraine is based on a small but reasonably designed clinical trial performed by widely respected investigators in Belgium. The trial showed benefits that were comparable to those of other migraine preventive therapies — that is to say statistically significant but not spectacular reduction in the frequency of migraine days,” said Andrew Charles, MD, who runs the Headache Research and Treatment Programs at UCLA’s David Geffen School of Medicine.
“Early experience of our patients who obtained these devices from Canada indicates that the stimulation may be uncomfortable, but otherwise there do not seem to be any serious adverse effects,” Charles said in an email to National Pain Report.
“My overall impression is that it is an approach that is worthy of further study. I can’t enthusiastically recommend it to patients at this time because of the limited evidence, the cost, and the time commitment required. On the other hand, if patients want to try it despite these caveats, I tell them to go ahead.”
About 31 million adult Americans suffer from migraine. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.
The Cefaly stimulator is made by the STX-Med company in Belgium.
The company says the Cefaly device will be available in early April to migraine patients in the U.S. by prescription-only. It can be ordered at www.cefaly.us. The cost is $295 plus $29 shipping.
A company produced video of the stimulator can be seen here:
Another recent study of the Cefaly device found that over half of the migraine sufferers who tried it were so satisfied at the conclusion of a 40-day study that they decided to purchase the device.
Over 2,300 migraine sufferers volunteered to try the device in a study published online in the Journal of Headache and Pain. The participants lived in Belgium, France or Switzerland; three countries where they could rent or buy the Cefaly stimulator over the Internet without a medical prescription.
At the conclusion of the study, over 54% of the participants were satisfied with the treatment and were willing to purchase the device. The remaining 46% of the Cefaly renters were not satisfied and returned it – although a compliance check found that many had not used the device for the recommended time and some never even turned it on.
Side effects such as fatigue, insomnia, and pain were reported by about 4% of the patients.
In December, 2013 the FDA approved the marketing of the first transcranial magnetic stimulation (TMS) device for the relief of pain caused by migraine preceded by an aura. Studies show the device is effective about a third of the time.
The Cerena TMS is a handheld prescription device meant to be used after the onset of migraine pain. The device is placed at the back of the head to release a pulse of magnetic energy to the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches.