The U.S. Food and Drug Administration (FDA) announced on Friday its approval for the marketing of a new migraine device, known as the Cerena Transcranial Magnetic Stimulator (TMS). It’s the first device that relieves migraine pain caused by an aura — a sight, sound, or “motor disturbance” that is damaging enough to cause the headache.
“Millions of people suffer from migraines, and this new device represents a new treatment option for some patients,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement.
The device, which would be available by prescription, works by being held to the back of the head. When the person presses a button, pulses of magnetic energy are released, stimulating the occipital cortex. In theory, this device would stop, or at least somewhat reduce, the migraine pain caused by aura.
Migraines are a severe type of headache, characterized by pulsing or throbbing in a certain area of the head. Sometimes migraines with aura are associated with vomiting, nausea, or sensitivity to light and sounds.
The FDA conducted a study that reviewed some 201 patients with moderate to strong migraines with auras. Of those who used the Cerena TMS, 38 percent said they felt the pain had been reduced significantly two hours after using it, compared to 17 percent of people in the control. Meanwhile, 34 percent of those who had used the device reported that they were pain-free after 24 hours. However, it’s uncertain whether the people who used the device may have experienced a placebo effect.
The FDA did note that dizziness may occur when using the device, but that overall adverse effects were uncommon. There were a few reports of sinusitis, aphasia, and vertigo. The FDA recommends using the device no more than once every 24 hours, and it is only approved for use in people over the age of 18. The Cerena TMS device should not be used by those who have metals in their head, neck, or upper body, nor should it be used by those with pacemakers or deep brain stimulators, people with a history of epilepsy or seizures, or any other active implanted medical device.
The TMS may be a sufficient option for those who suffer from migraines but want to avoid taking too many painkillers.