FDA Approves 1st Device to Combat Migraine Headaches

FDA Approves 1st Device to Combat Migraine Headaches

December 16th, 2013 // 3:09 pm @

FDA announced last week that it had approved the first medical device ever to relieve migraine pain. The Cerena single pulse transcranial magnetic stimulation device has been shown in a 201 patient clinical trial to be effective in relieving migraine pain for 38% of patients within two hours. And 34% were pain free within 24 hours.

The patient applies the handheld device to the back of the head and presses a button for a total of two pulses. Each is .9 Tesla and lasts less than a millisecond each.

In the trial, some patients were treated with a fake device and had two and 24 hour response rates of 17% and 10%.

The clinical study didn’t show that the Cerena TMS is effective to relieve related symptoms of migraines, such as light sensitivity, sound sensitivity and upset stomach.

The most likely adverse effect is dizziness, and there have been a few cases of sinusitis and aphasia in the clinical trials.

The medical device utilizes magnetic energy to stimulate the occipital cortex, which is the area of the brain that does visual processing.

Migraine headaches last from four to 72 hours if they are not treated. They affect about 10% of the world population and are three times more common in females than males.

Patients should not use the Cerena TMS if they have any metal plates in their head, upper body or neck that are attracted by magnets. You also should not use it if you have a pacemaker or a deep brain stimulator.

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