A new device is approved to treat migraine with aura.

Transcranial magnetic stimulation (stimulation of the brain with a magnetic field) has been researched for over 30 years. It has been used to study the brain and to treat a variety of conditions, such as depression, Parkinson’s, strokes, pain, and other. The U.S. Food and Drug Administration has “allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.”

Here is an excerpt from the FDA News Release:

“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.

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.

Patients must not use the Cerena TMS device if they have metals in the head, neck, or upper body that are attracted by a magnet, or if they have an active implanted medical device such as a pacemaker or deep brain stimulator. The Cerena TMS device should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures. The recommended daily usage of the device is not to exceed one treatment in 24 hours.”

After 30 years of research we know that the risks of TMS are minimal, although theoretically, TMS induces an electric current in the brain, similarly to what happens with electric shock therapy, but to a much milder degree. TMS treatment of migraines does not appear to cause memory or any other problems seen with electric shock therapy for depression.

The main problem with this device is that it is bulky and inconvenient to carry around. It will probably will be reserved for people who have severe migraines that do not respond to preventive and abortive medications and Botox injections and cause disability. Considering its inconvenience, cost, and the fact that only 15% to 20% of migraine sufferers have auras (most of whom can be treated with medications or Botox), this device is not likely to be used widely. But for those for whom it works, it could be life changing.

Photo credit: www.eneura.com

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