Aura Migraine Treatment Device Approved by FDABy: Sean Patterson - December 16, 2013
The U.S. Food and Drug Administration (FDA) has approved the first device for the treatment of aura migraines. Aura migraines are described by the agency as severe migraine headaches preceded by a visual, sensory, or motor disturbance – and “aura.”
The approved device is known as the Cerena Transcranial Magnetic Stimulator (TMS). The device is designed to be used after a migraine has already begun. Patients suffering from a migraine hold the TMS against the back of their head and press a button. The TMS then releases a “pulse of magnetic energy” that stimulates the occipital cortex, sometimes relieving migraine pain. The device is meant to be used once per day.
“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 at the FDA.
The Cerena TMA was approved following and FDA review of a clinical trial involving over 200 patients. The trial found that 38% of study participants who used the device had their migraine pain subside two hours after.
Though the trial found that the TMS may relieve headach pain from migraines, it did not show that the device can relieve other symptoms associated with migraines. Light sensitivity, sound sensitivity, and nausea (all common migraine symptoms) were not affected by the device.
The FDA has stated that the Cerena TMS is for the treatment of aura migraines only and that it is not for use by those younger than 18 or those with epilepsy. It is also not recommended for those with metals in their head or neck or people with a pacemaker, deep brain stimulator, or other type of implanted device. The device may also be associated with dizziness.
(Image courtesy eNeura Therapeutics)