The Cerena single-pulse transcranial magnetic stimulation device is manufactured by eNeura Therapeutics LLC, a Sunnyvale, Calif.-based developer of portable, non-invasive Transcranial Magnetic Stimulation (TMS) products for migraine treatment. The handheld Cerena device delivers a brief magnetic pulse to the back of the head for pain relief.
In a 201-patient pivotal trial underlying the FDA's approval, patients applied the Cerena device to the back of the head and pressed a button to administer two pulses, each approximately 0.9 Tesla and lasting less than a millisecond, 30 seconds apart.
Roughly 38 percent of patients reported that migraine pain was eliminated within two hours, and 34 percent were pain-free 24 hours later. In comparison, patients treated with a sham device had two- and 24-hour response rates of 17 percent and 10 percent, respectively, the FDA said. A total of 113 patients experienced a migraine during the study period and were included in the analysis.
"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 agency noted in announcing the approval.
Dizziness is the most likely adverse effect. The FDA noted that there had been single cases of sinusitis and aphasia in the device's trials.
Patients with ferrous metal implants or devices with magnetic components must not use the Cerena device, nor should patients with epilepsy or any personal or family history of seizures, the FDA said. Only one treatment should be delivered every 24 hours.
The device had previously been approved for use in Great Britain where it is sold as the Spring TMS Total Migraine System.
A migraine is more than merely a bad headache—it is a chronic and often debilitating neurological disease that affects nearly 12 percent of the world’s population, according to industry statistics. An estimated 30 million Americans suffer from migraines. Symptoms typically include excruciatingly painful headaches, nausea, and sensitivity to light and sound. More than half of migraine patients report severe impairment or require bed rest during their episodic attacks.