On December 13, the FDA approved the Cerena Transcranial Magnetic Stimulator, which is made by eNeura. The Cerena TMS is a device used after the onset of pain associated with Migraine with 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.
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. Of the study subjects, 113 recorded treating a migraine at least once when pain was present. Analysis of these 113 subjects was used to support marketing authorization of the Cerena TMS for the acute treatment of pain associated with migraine headache with aura.
The study showed that nearly 38 percent of subjects who used the Cerena 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. After 24 hours, nearly 34 percent of the Cerena TMS users were pain-free compared to 10 percent in the control group.
The study did not show that the Cerena TMS is effective in relieving the associated symptoms of migraine, such as sensitivity to light, sensitivity to sound, and nausea. The device is for use in people 18 years of age and older. The study did not evaluate the device’s performance when treating types of headaches other than migraine headaches preceded by an aura.
Adverse events reported during the study were rare for both the device and the control groups but included single reports of sinusitis, aphasia (inability to speak or understand language) and vertigo (sensation of spinning). Dizziness may be associated with the use of the device.
Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, commented:
"Millions of people suffer from migraines and this new device represents a new treatment option for some patients."1
Don’t run to your doctor to ask about this device though. The FDA approved the Cerena, which is a first generation device that eNeura used in early clinical trials. Although the Cerena has been approved by the FDA, eNeura is not going to manufacture and market it.
Instead of marketing the Cerena, eNeura will be submitting their newer TMS device, the SpringTMS, to the FDA for approval early this year. You can see the SpringTMS in the photo above. Once the SpringTMS received FDA approval, it will be introduced slowly through U.S. Migraine and Headache clinics. Since this is such novel technology, eNeura wants to ensure the best patient support and service possible. Thus, the planned slow roll-out. It’s hoped that now that the Cerena has been approved, approval of the SpringTMS will take a shorter time and that the SpringTMS will be available in mid 2014.
We’re not there yet, but approval of the Cerena device does bring us a step closer to having this technology available to treat Migraine.
For more information about TMS and the clinical trials mentioned above, see
_Transcranial Magnetic Stimulation (TMS) for Migraine _.
1 News Release: FDA allows marketing of first device to relieve migraine headache pain." Food and Drug Administration. December 13, 2013.
2 Interview. Teri Robert with Terese M. Baker; Vice President, Marketing; eNeura Therapeutics, LLC. December 19, 2013.
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Teri Robert is a leading patient educator and advocate and the author of Living Well with Migraine Disease and Headaches. A co-founder of the Alliance for Headache Disorders Advocacy and the American Headache and Migraine Association, she received the National Headache Foundation’s Patient Partners Award and a Distinguished Service Award from the American Headache Society. Teri can be found on her website, and blog, Facebook, Twitter, StumbleUpon, Pinterest, LinkedIn, and Google+.