Neurostimulation treatment for migraines scored another win in a new study published in The Journal of Headache and Pain. Theranica Bio-Electronics‘ Nerivio compared favorably with usual care and medication for acute migraines.
We wrote about Theranica’s technology twice before. In 2017, shortly after the FDA approved the Nerivio Migra as a clinical investigational device, we described the basics of operation. Rather than applying neurostimulation close to the pain’s location, i.e. on the head, the Nerivio device is an armband placed just below the shoulder above the triceps muscle. This remote electrical neuromodulation (REN) sends impulses to the central nervous system (CNS) to activate a natural analgesic neurotransmitter in the brain.
Earlier this year we wrote that the FDA cleared the Nerivio Migra for use with migraines based on a study that showed patients using the device had nearly twice the relief of those who used a sham device.
The latest study compared Theranica’s Nerivio device to conventional acute care in the same patients. The study was designed to prove the non-inferiority of the REN treatments compared to usual care. After two to four weeks of usual care, the patients were treated with the REN device or a sham device. Of the 99 patients who completed the full process, two hours following treatment with the Nerivio device, more patients (67%) had pain relief than with the usual acute care treatment including medications (52.5%).
The study concluded that Theranica’s Nerivio was indeed non-inferior to usual care for acute migraine. In light of the Nerivio safety profile, the study also concluded that REN could be a possible alternative treatment of migraine and the first line treatment for some patients.
