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FDA Clears Magnet Treatment For Migraines

black woman with migraine

A magnetic device that repels the often debilitating symptoms of migraines is headed to the U. S. market.
The federal Food and Drug Administration today approved the Cerena Transcranial Magnetic Stimulator, the first device to relieve pain caused by migraine headaches preceded by auras, visual, sensory or motor disturbances immediately before the onset of a migraine attack.

A migraine, which can last anywhere between four and 72 hours when untreated, is characterized by intense pulsing or throbbing pain in one area of the head, often accompanied by nausea, vomiting and sensitivity to light and sound.
The debilitating attacks affect approximately 10 percent of the world’s population and are three times more common in women than in men. About one-third of all sufferers experience an aura.

“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 that’s used after the onset of the pain associated with migraine headaches preceded by auras. A user would hold the TMS against the back of the head with both hands and then press a button to release a pulse of magnetic energy that, according the FDA, stimulates the occipital cortex in the brain, resulting in a reduction of the migraine pain or stopping it altogether.

The FDA reviewed a randomized control clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30 percent of their migraines. During the study, 113 of the subjects recorded treating a migraine at least once when pain was present.

Nearly 38 percent of the subjects who used the TMS when they had migraine pain were pain-free two hours after using the device, compared to about 17 percent of patients in the control group who didn’t use the device. After 24 hours, nearly 34 percent of the TMS users were pain-free compared to about 10 percent of the control group.

The research, however, did not demonstrate if the device’s effectiveness in relieving the associated symptoms of migraines — light and sound sensitivity and nausea. Nor did the study examine the device’s performance in treating types of headaches other than the migraines with auras.

Read more: Latin Post

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