First device to treat migraine wins FDA approval

Date: Dec-16-2013The Cerena Transcranial Magnetic Stimulator, the first medical device for the treatment of

migraine headaches preceded with aura, has won regulatory approval in the United States.

On Friday, the US Food and Drug Administration (FDA) announced it had allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS),

manufactured by eNeura Therapeutics of Sunnyvale, CA, for use under prescription, for the relief of pain caused

by migraines that are preceded by an aura.

Migraine affects one in 10 people worldwide

A migraine is an intense pulsing or throbbing pain in part of the head, accompanied by nausea and sometimes

vomiting, plus heightened sensitivity to light and sound. The debilitating condition can last from 4 up to 72

hours if not treated.

Migraines affect one in 10 people worldwide, with women three times more likely to experience them than

men. Around one in three migraine sufferers also experiences an aura - a visual sensory or motor disturbance

that precedes the headache itself.

Researchers claim that a pulse of magnetic energy may hold the key to migraine relief - a condition that affects three times as many women as men.

The operas of the German composer Richard Wagner are thought to reflect the influence of his disabling

migraine headaches.

For example, in a paper published in the Christmas edition of The BMJ, researchers describe how the opening of Wagner's Siegried develops like a

migraine.

The Cerena TMS, which is available on prescription only, is used after the pain of migraine preceded with

aura has started.

The patient holds the device with two hands against the back of the head. When they press a button, it

releases a pulse of magnetic energy through the skull into the occipital cortex. The idea is that by

stimulating this part of the brain, the pulse either lessens or stops the pain.

The FDA reviewed pre-market data and the results of a clinical trial of the Cerena TMS

The FDA notes in its announcement that it "reviewed the data for the Cerena TMS through the de novo

pre-market review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not

substantially equivalent to an already legally marketed device."

A randomized controlled trial of 201 patients showed that nearly 38% of those using the TMS when they had

migraine were pain-free for 2 hours after, compared with 17% of the controls.

After 24 hours, 34% of the TMS users were pain-free compared with 10% of the controls.

The trial did not find that the device effectively relieves symptoms associated with migraine, such as

sensitivity to light and sound, or nausea.

The device is for patients aged 18 and over and recommended daily use should not exceed one treatment in 24

hours, says the FDA.

Patients who have magnetic metals in the head, neck or upper body must not use the device, and neither must

people with pacemakers, deep brain stimulators, or other forms of implanted devices.

Patients with suspected or diagnosed epilepsy or a personal or family history of seizures should also not

use the device.

Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and

Radiological Health, says:

"Millions of people suffer from migraines and this new device represents a new treatment option for some

patients."

In July 2013, researchers at the University of Pennsylvania writing in PLOS ONE, suggested deficits in

brain artery structure could be a cause of

migraine.

Written by Catharine Paddock PhD

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