Migraine is a neurological disease that affects 12% of the population, worldwide according to the Migraine Research Foundation. Pharmaceutical treatments for migraine range from over-the-counter acetaminophen to antidepressants. We’ve written several times about the use of neurostimulation to treat migraines, including eNeura’s study with the Mayo Clinic with single-pulse Transcranial Magnetic Stimulation, electroCor’s gammaCore electrical vagus nerve stimulation, Cefaly’s e-TNS neurostim, and more.

In 2017 we wrote about the unique form of stimulation with Theranica Bio-Electronic‘s Nerivio Migra armband. Theranica’s device stimulates the central nervous system to activate a natural analgesic neurotransmtter in the brain. Two years ago the FDA approved the Nerivio Migra as a clinical investigative device. Now Theranica is back in the news with FDA clearance for Nerivio Migra used with a smartphone app to treat acute migraine with remote electrical neuromodulation (REN).

The FDA’s clearance to market Nerivio Migra was based on the results of a randomized, double-blind, sham-controlled study published in Headache: The Journal of Head and Face. The study at 12 sites in the U.S. and Israel involved 252 adults who suffer from migraine headaches 2-8 times per month. The adults used the smartphone-controlled wireless armband for 30 to 45 minutes within one hour of the onset of the migraine attack. According to the researcher, the Nerivio Migra device provided pain relief for 66.7% of the subjects, nearly twice as often as the relief reported by 38.8% of the subjects with a sham device.

The Nerivio Migra isn’t a miracle cure for migraine pain. One-third of the subjects in the study who use the device didn’t report pain relief. However, even though nearly 40% of the patients with a placebo device reported relief from pain, the Nerivio Migra’s results were significantly greater than the sham control device. Even without 100% effectiveness, adding a non-pharmaceutical treatment to the arsenal of physician’s options for treating migraine is a win.