FDA now allows marketing of the Cerena Transcranial Magnetic Stimulator (TMS) manufactured by eNeura Therapeutics of Sunnyvale California. The Cerena TMS the first device to relieve pain caused by migraine headaches 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 that may stop or lessen the pain associated with migraines.
FDA reviewed a randomized control clinical trial of 201 patients that had mostly moderate to strong migraines with auras preceding at least 30 percent of their migraines. Of the study subjects, 113 reported treating a migraine at least once when pain was present.
The study showed that nearly 38 percent of the subjects who used the Cerena TMS when faced with migraine pain were pain free two hours after using the device as compared to about 17 percent of patients in the control group. After 24 hours, nearly 34 percent of the users were pain free compared to ten percent in the control group.
Adverse events reported during the study were rare for both the device and the control groups but included single reports of sinusitis, aphasia, and vertigo. Dizziness may also be associated with the use of the device.
Patients must not use the Cerena TMS device if they have metals in the head, neck, or upper body that are attracted by a magnet, of if they have an active implanted medical device such as a pacemaker or deep brain stimulator. Also, the device should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures.