The U.S. Food and Drug Administration (FDA) has approved the first device designed to ease the pain of migraine sufferers whose migraines are preceded by aura. Approximately one-third of all migraine sufferers experience aura.
According to the FDA statement, “Millions of people suffer from migraines, and this new device represents a new treatment option for some patients,” said Christy Foreman, Director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. The stimulator is manufactured by eNeura Therapeutics and is not for use more than once every 24 hrs. the statement indicated. It also has also not been tested to determine its efficacy regarding other symptoms of migraine like nausea or sensitivities to light or sound.
Only those eighteen years and older are approved to use the device which is available by prescription only and should never be used in anyone with suspected epilepsy or a family history of seizures, the FDA said.
“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 such as a pacemaker or deep brain stimulator,” the FDA said.
According to the FDA release more than 38 percent of people using the stimulator said they were pain-free two hours later as compared to 17 percent of patients who did not use the device. Twenty-four hours after the onset of a migraine, nearly 34 percent of device users said they were pain-free, compared to 10 percent of people who had not used the device at all. Reported side effects from the device were said to be rare but include vertigo, “single reports of sinusitis” and aphasia or an inability to speak or understand language.
Patients will be required to use both hands to hold the device against the back of their head and depress a button. In so doing, the device will release a pulse of magnetic energy. This pulse stimulates the brain’s occipital cortex and this may stop or ease the pain. The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a statement released Friday 13th December.
One-hundred and thirteen of the patients tried treating their migraines while an attack was in progress, and their reports led to the approval of the new device, the FDA said. The agency’s approval is based on a trial involving 201 patients who had suffered moderate-to-strong migraine with aura.
