Mi-Helper, Inc. has partnered with ObvioHealth to conduct a pioneering clinical trial for a non-invasive neuromodulation device designed to treat migraines. The randomized controlled trial will be fully remote, enabling patients to participate from the comfort of their own homes. The partnership aims to develop a more effective, targeted, and drug-free pain management solution for the one billion people worldwide who suffer from migraines.
The small Mi-Helper device is designed to provide relief from migraine-related pain and associated symptoms, such as nausea and photosensitivity, by delivering a controlled stream of conditioned air with a nebulized mist to the mucosa membranes in the nose. The clinical trial will have an adaptive design, starting with the establishment of optimal dosing and culminating in a pivotal trial to determine therapeutic efficacy. The ObvioGo app will enable patients to remotely enroll, consent, and report relief of pain and other migraine symptoms, as well as the use of rescue medications and any potential adverse events. ObvioHealth’s COACH team will remotely monitor patient compliance and safety in near real-time.
The study will recruit patients from all over the continental United States, including underserved communities, providing Mi-Helper with essential data on a real-world population in a real-world setting. The remote clinical trial is expected to start recruiting in the summer, and the partnership is committed to delivering fast, accessible, and affordable relief for this highly complex and debilitating neurological disease.