SILVER SPRING, Md. — The Cerena single-pulse transcranial magnetic stimulation device may be sold for relieving migraine pain, the FDA said late Friday.
In the 201-patient pivotal trial underlying the approval, patients applied the handheld 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.
Some 38% of patients reported that migraine pain was eliminated within 2 hours, and 34% were pain-free 24 hours later. In comparison, patients treated with a sham device had 2- and 24-hour response rates of 17% and 10%, 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 Cerena device is manufactured by eNeura Therapeutics of Sunnyvale, Calif. The device had previously been approved for use in Great Britain where it is sold as the Spring TMS Total Migraine System.
http://www.medpagetoday.com/Neurology/Migraines/43439
Picture courtesy to www.butyoudontlooksick.com
Constantine Moschonas, MD 