The first device designed to prevent migraines has won first approval for marketing from the U.S. Food and Drug Administration (FDA). Researchers developed the technology to treat patients unable to tolerate medications available to prevent or treat these headaches.
STX-Med, a Belgian firm, manufactures the Cefaly device, available by prescription to individuals at least 18 years old, according to Medical News Today. The FDA says patients should use it a maximum of once a day for 20 minutes.
The National Headache Foundation reports that more than 37 million Americans experience migraine headaches. As many as 80 percent of them have a family history of these headaches.
Migraines tend to make their first appearance when patients are between 10 and 45 years old but can develop later. They occur far more often in women than in men. According to MedlinePlus, the cause is abnormal brain activity triggered by a variety of factors. A majority of experts think a migraine attack starts in the patient’s brain, involves chemicals and nerve pathways, and results in changes that affect blood flow in the brain and in the tissues surrounding it.
Healthcare providers have no specific cure to offer for migraines. Some patients aren’t able to use any of the medications currently available to control or prevent attacks.
The Cefaly device is a small plastic headband worn across a patient’s forehead. The individual attaches the battery-powered device above the eyes with a self-adhesive electrode. The technology sends a low-voltage electric current through the patient’s skin to stimulate the trigeminal nerve, one linked to migraines. Sensations can resemble tingling or massaging.
Before issuing its initial approval, the FDA looked at a Belgian study with 67 patients. These individuals had at least two attacks every month and had stopped taking medication for migraines for three months prior to the clinical trial.
Scientists compared results from patients using the Cefaly device with those from subjects using dummy technology. Cefaly subjects experienced fewer migraine days each month and used less medication than the other patients. However, the device didn’t prevent all migraine attacks or reduce the intensity of those that did occur.
The FDA also reviewed a patient satisfaction study that involved 2,313 individuals in Belgium and France who used the Cefaly device. Findings stated that 53 percent of the subjects were satisfied with their treatment and would purchase the device to use it in the future.
Neither study found serious adverse affects from using the device. Some users complained about the sensation during their treatments, feeling sleepy while using the headband, and/or experiencing a headache after a session.
A marketing nod for Cefaly follows the FDA’s December 2013 approval of the Cerena Transcranial Magnetic Stimulation, a prescription item patients who suffer from migraine with aura use once pain has begun.
Vonda J. Sines has published thousands of print and online health and medical articles. She specializes in diseases and other conditions that affect the quality of life.