ObvioHealth has partnered with Mi-Helper to conduct a decentralized clinical trial for a non-invasive neuromodulation device that aims to provide relief from migraine-related pain. The randomized controlled trial will be fully remote, allowing for data capture from home where the device is intended to be used. The small Mi-Helper device delivers a controlled stream of conditioned air with a nebulized mist to the mucosa membranes in the nose.
Migraines affect one billion people worldwide, and severe headaches are among the top causes of emergency room outpatient visits in the United States. In a recent study, 40% of migraine sufferers reported dissatisfaction with current treatments due to lack of efficacy, poor tolerability, and contraindications to common migraine-specific medications.
The Mi-Helper study features 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 (Clinical Oversight And Coordination Hub) team will remotely monitor patient compliance and safety in near real-time.
The study is expected to begin recruiting this summer.