People who suffer from migraine headaches have two new devices to help. As we’ve noted before, approximately one-quarter of all U.S. households include a migraine sufferer. More than 12% of the population have migraines. Many people can detect an incipient migraine, noting what’s referred to as an “aura.” Noting a migraine warning, some people find success with preventative measures. Many migraine patients do not get warnings, however, and once a migraine starts, many people succumb to deepening levels of pain that take over their lives until the pain subsides. This time-out from life typically lasts 4 to 72 hours.
In late 2015, we wrote about Cefaly‘s Cefaly, an FDA-approved, prescription-only neurostimulation wearable used to prevent oncoming migraines. This prophylactic device includes a headband with an e-TNS neurostim unit in the center. The patient places the headband’s center on an adhesive electrode positioned on the center of the forehead. Repeated use of the device to stimulate the trigeminal nerve has a sedative effect that reduces migraine frequency. The FDA recently approved two more Cefaly neurostim devices based on the same general principles: Cefaly Acute and Cefaly Dual. The company renamed the original device Cefaly Prevent. The FDA approved Cefaly Acute for use stopping a migraine that has already started. Cefaly Dual includes both of the e-TNS modes: prophylactic and treatment.
FDA approval considered the results of a double-blind, randomized placebo trial presented to the International Headache Society. A one-hour e-TNS treatment with Cefaly Acute reduced migraine pain by 65%, on average. Also, 32% of patients were pain-free within an hour. The three Cefaly devices are available by prescription only.