The FDA has allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS) – the first device to alleviate pain caused by migraine headaches that are preceded by an aura. An aura is a visual, sensory or motor disturbance preceding the onset of a migraine attack.

“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 Cerena TMS is a prescription device. Using both hands to hold the device against the back of the head, the user presses a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain. This may stop or lessen the migraine pain.

The FDA reviewed a clinical trial of 201 patients who had moderate to severe migraine headaches, and who had auras preceding at least 30% of their migraines. Of the participants, 113 recorded treating a migraine at least one time with the TMS, when they felt pain. The study showed that close to 38% of the patients who used the device were pain-free two hours after using it, compared to about 17% of patients in the control group. Nearly 34% of the TMS users were free of pain after 24 hours, compared to 10% of the control group.

The study did not look at the device’s performance when treating types of headaches other than migraine headaches preceded by aura. Nor did the study show that the device is helpful in relieving other symptoms of migraine, including sensitivity to light, sensitivity to sound, and nausea.

There were some single reports of sinusitis, aphasia (inability to speak or understand language) and vertigo (sensation of spinning). It may cause dizziness in some people.

If patients have metals in their head, neck, or upper body that are attracted by a magnet, or if they have an active implanted medical device like a pacemaker, or deep brain stimulator they should not use the device. And, the device should not be used in patients with suspected or diagnosed epilepsy, or a personal or family history of seizures. The recommended daily usage is no more than one treatment every 24 hours.

The device, which is expected to be available sometime in early 2014 is manufactured by eNeura Therapeutics of Sunnyvale, California.   FDA News Release    12/13/2013



Pin It on Pinterest