FDA Approves for Device for Migraine with Aura

On Friday the FDA approved the Cerena Transcranial Magnetic Stimulator (TMS) for the use of migraine pain relief in migraine with aura.  The FDA described the device in this way:

The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches 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 to stimulate the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches preceded by an aura.

We actually talked about this device over a year ago, but you might not recognize the name.  The Cerena TMS is already being sold in the UK as the SpringTMS Total Migraine System.  It’s available with prescription at various locations throughout England.

Although the FDA already considered the device to be generally safe, they were going through the regular procedure to approve devices.  One thing they needed was a clinical trial – and the trial they used was funded by the makers of the Cerena TMS.  However, you’ll be glad to hear that it was a well controlled study done by many of the big names in migraine research and treatment.

In the study, 201 patients with migraine with aura were treated with a real or sham device over 3 months.

Of the patients that treated a migraine attack with the TMS device, 39% were pain-free within two hours.  Most of these patients remained pain-free one and two days later.  That’s good news, because it seems that the device was able to actually stop the attack, not just mask the symptoms.  Here’s the abstract:  Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura

More trials will be needed to see if the device is effective for migraine without aura, and to see how it impacts other common migraine symptoms.  The FDA approval is simply confirmation that the organization feels the device is generally safe, and that it can help some people.

For more information:

• FDA Press Release about the Cerena TMS
• eNeura Therapeutics’ Cerena TMS gets FDA clearance for migraine treatment
• eNeura website