The Food and Drug Administration has approved the marketing of the first transcranial magnetic stimulation (TMS) device for the relief of pain caused by migraine headaches preceded by an aura. Studies show the device is effective about a third of the time.
The Cerena TMS is a handheld prescription device meant to be used after the onset of migraine pain. The device is placed at the back of the head to release a pulse of magnetic energy to the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches.
“Millions of people suffer from migraines and this new device represents a new treatment option for some patients,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
About 31 million adult Americans suffer from migraine. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to sound and light (aura).
TMS had previously been approved by the FDA to treat depression, but it is also being used off-label to treat addiction, fibromyalgia and migraines.
TMS generates highly concentrated magnetic fields to target a part of the brain involved with mood regulation. The magnetic fields produce small electric currents that activate cells within the brain, which are thought to release neurotransmitters (serotonin, norepinephrine and dopamine), chemical messengers that improve mood and make depressed people feel better.
The FDA reviewed the Cerena TMS device in a small clinical trial of 201 patients who had mostly moderate to strong migraine headaches, and who had auras preceding their migraines at least 30% of the time.
The study showed that nearly 38% of the patients who used the Cerena TMS were pain-free two hours after using the device, compared to about 17% of patients in a control group. After 24 hours, nearly 34% 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 other migraine symptoms, such as sensitivity to light, sensitivity to sound, and nausea. Nor did the study evaluate the device’s performance when treating other types of headaches besides migraines.
The FDA reviewed the Cerena TMS through a regulatory pathway for low- to moderate-risk medical devices that are not similar to an approved device already on the market. The device is only approved for people 18 years of age and older.
The FDA said dizziness may be a side effect of using the device.
The Cerena device is manufactured by eNeura Therapeutics of Sunnyvale, California. The device has already been approved for use in Great Britain where it is sold as the Spring TMS Total Migraine System.
A similar device worn on the head uses neurostimulation to deliver small electrical signals to a nerve center in the brain to prevent or treat migraines and headaches. Wearing the stimulator for just 20 minutes a day reduces the number of migraines just as effectively as migraine drugs or other types of migraine therapy, according to a small study published in Neurology, the medical journal of the American Academy of Neurology.