The U.S. Food and Drug Administration (FDA) has approved the first device aimed at easing the pain of a specific type of migraines, reports HealthDay. The category of migraines targeted is those preceded by aura, which are sensory disturbances that occur just before an attack. Aura migraines occur in approximately one-third of migraine sufferers.
The approved product, which is the Cerena Transcranial Magnetic Stimulator, would be obtained by migraine sufferers through prescription from their doctors. To use the device, patients use both hands to hold the device against the back of their head and press a button so that the device can release a pulse of magnetic energy. This pulse stimulates the brain’s occipital cortex, which may stop or ease migraine pain.
The new device is approved only for use by those aged 18 or older, and should not be used by people with suspected or diagnosed epilepsy or a family history of seizures. It should also not be used by anyone with any metal device implanted in the head, neck or upper body, or people with an active implanted medical device. Side effects were generally rare, but included anecdotal reports of sinusitis, aphasia, and vertigo.
According to the Mayo Clinic, a migraine headache can cause intense throbbing or a pulsing sensation in one area of the head and is commonly accompanied by nausea, vomiting, and extreme sensitivity to light and sound. Migraine attacks can cause significant pain for hours to days and be so severe that all the sufferer can think about is finding a dark, quiet place to lie down. Some migraines, such as those targeted by the new device, are preceded or accompanied by sensory warning symptoms (aura), such as flashes of light, blind spots, or tingling in the arms or legs.
The agency’s approval of the new device is based on a trial involving 201 patients who had suffered moderate-to-strong migraine with aura. Of the study participants, 113 tried treating their migraines while an attack was in progress. This group’s testimony was instrumental in helping the device gain FDA approval. More than one-third (38 percent) of people using the stimulator reported being pain-free two hours later, as compared to 17 percent of the patients who did not use the device. A full day after the onset of migraine, nearly 34 percent of device users said they remained pain-free, as compared to 10 percent of people who had not used the device.