The investigational Nocira Automated Variable Pressure Insufflation system is controlled via Bluetooth by a downloadable mobile phone app. Image courtesy of Nocira.
The investigational Nocira device for acute migraine treatment non-invasively creates precisely controlled patterns of gentle air pressure changes in the outer ear. This stimulates unique pressure-activated nerve receptors, found only in the ear, that Nocira’s researchers hypothesize target and reset pain centers in the brain.
Nocira presented its clinical pilot study data in September at the International Headache Congress in Dublin, showing that 20 out of 30 subjects were completely pain free, and 28 out of 30 had at least 50% relief, after just a 20-minute treatment with the device. “Contextually, this complete pain freedom rate is about double the published rates for current migraine drugs and devices,” Jim Peacock, CEO for Nocira, told MD&DI. “Current treatments are also limited for use in only the first hour of a migraine, called the ‘mild’ headache window—but with poor patient compliance, including waiting longer to use drugs due to side effect concerns. Nocira’s successful pilot results reflect treating higher intensity ‘moderate-to-severe’ migraines, including at later stages, and also in a cohort of chronic patients—factors considered more resistant to treatment.” The company plans a larger multi-center trial to support regulatory submission for pre-market clearance within the next year.
Nocira’s system includes a smartphone app connected to a small air pressure regulation device via Bluetooth. The patient opens the app and enters information about the migraine symptoms. The app then controls the device to vary patterns of subtle ear pressure changes through a thin tube that splits into comfortable earbuds. The system also learns and optimizes which patterns work best for each migraine attack in each individual patient. Nocira recognizes the high potential value of data capture and analytics. “The app is being designed to securely monitor real-time treatment data and to integrate with other real-world patient information,” David George, Nocira’s chief scientific officer, told MD+DI. “This provides a digital health platform, in which we are also incorporating AI for continual optimization and improvement.” The company is engaging AI consultants and other partners in fulfilling that continual improvement commitment.
FDA approved four migraine treatment devices in just the past five years: eNeura Spring TMS, which uses single-pulse transcranial magnetic stimulation (eNeura Inc., Baltimore); gammaCore, noninvasive vagal nerve stimulation (electroCore, Basking Ridge, NJ); Cefaly, transcutaneous supraorbital neurostimulation (Seraing, Belgium); and Nerivio Migra, remote electrical neuromodulation (Theranica, Netanya, Israel). Nocira’s patented approach is differentiated by using pressure in the ear as a new neuromodulation platform. But the biggest draws of the Nocira approach may be how pleasant the treatment itself feels, and how unobtrusive and easy the device is to use.
“The Nocira device is designed to fit easily in a pocket as a hands-free, consumer-friendly product,” says Peacock. “It looks and feels more like enjoying a new electronic consumer device, e.g. for listening to music, vs. giving yourself a medical treatment—and can be comfortably used anywhere, anytime.” In addition to providing rapid migraine relief, the pleasurable, calming effect may also offer the possibility of other applications for the device, such as treating stress/anxiety and insomnia, according to the company.