Magnet therapy may have been around for some time but the recent decision of the U.S. Food and Drug Administration (FDA) to approve a magnetic device for migraine treatment may just give this field of alternative medicine a boost.
The FDA has approved and allowed the marketing of the Cerena Transcranial Magnetic Stimulator, a device for relieving pain caused by migraines. Its use has already been approved in Great Britain where it is sold as the Spring TMS Total Migraine System.
"Millions of people suffer from migraines and this new device represents a new treatment option for some patients," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement. The debilitating headache affects 10 percent of the world's population and about a third of those affected experience an aura, a visual, sensory or motor disturbance that immediately precedes a migraine attack.
The Cerena TMS is used to treat pain caused by migraine headaches that are preceded by an aura. 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 that would stimulate the occipital cortex in the brain. This could stop or ease the pain associated with migraine headaches preceded by an aura.
FDA's approval is based on a randomized control clinical trial that involved 201 patients. The result of the study showed that 38 percent of the subjects who used the Cerena TMS were pain-free after two hours and 34% were pain-free 24 hours later. Patients who were treated with a sham device, on the other hand, had two and 24-hour response rates of 17% and 10%, respectively
Migraine sufferers will need prescription from their doctors to use the device. According to eNeura Therapeutics, manufacturer of the Cerena TMS, the device is not recommended for use by people with suspected or diagnosed epilepsy or those who have a family history of seizures. The Cerena TMS is also approved for use only by patients who are at least 18 years old. Patients who have a metal device implanted in their head, neck or upper body, and those with an active implanted medical device are likewise advised against using the device.