The Cerena Transcranial Magnetic Stimulator, the first medical device for the treatment of migraine headaches preceded with aura, has won regulatory approval in the United States.
On Friday, the US Food and Drug Administration (FDA) announced it had allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), manufactured by eNeura Therapeutics of Sunnyvale, CA, for use under prescription, for the relief of pain caused by migraines that are preceded by an aura.
A migraine is an intense pulsing or throbbing pain in part of the head, accompanied by nausea and sometimes vomiting, plus heightened sensitivity to light and sound. The debilitating condition can last from 4 up to 72 hours if not treated.
Migraines affect one in 10 people worldwide, with women three times more likely to experience them than men. Around one in three migraine sufferers also experiences an aura – a visual sensory or motor disturbance that precedes the headache itself.
The operas of the German composer Richard Wagner are thought to reflect the influence of his disabling migraine headaches.
For example, in a paper published in the Christmas edition of The BMJ, researchers describe how the opening of Wagner’s Siegfried develops like a migraine.
The Cerena TMS, which is available on prescription only, is used after the pain of migraine preceded with aura has started.
The patient holds the device with two hands against the back of the head. When they press a button, it releases a pulse of magnetic energy through the skull into the occipital cortex. The idea is that by stimulating this part of the brain, the pulse either lessens or stops the pain.
The FDA notes in its announcement that it “reviewed the data for the Cerena TMS through the de novo pre-market review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.”
A randomized controlled trial of 201 patients showed that nearly 38% of those using the TMS when they had migraine were pain-free for 2 hours after, compared with 17% of the controls.
After 24 hours, 34% of the TMS users were pain-free compared with 10% of the controls.
The trial did not find that the device effectively relieves symptoms associated with migraine, such as sensitivity to light and sound, or nausea.
The device is for patients aged 18 and over and recommended daily use should not exceed one treatment in 24 hours, says the FDA.
Patients who have magnetic metals in the head, neck or upper body must not use the device, and neither must people with pacemakers, deep brain stimulators, or other forms of implanted devices.
Patients with suspected or diagnosed epilepsy or a personal or family history of seizures should also not use the device.
Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, says:
“Millions of people suffer from migraines and this new device represents a new treatment option for some patients.”
In July 2013, researchers at the University of Pennsylvania writing in PLOS ONE, suggested deficits in brain artery structure could be a cause of migraine.