Mi-Helper and ObvioHealth Partner to Conduct Pioneering Decentralized Clinical Trial for Migraine Treatment Device

Body copy: Mi-Helper, Inc. has announced a partnership with ObvioHealth to conduct a decentralized clinical trial for a non-invasive neuromodulation device for the treatment of migraines. The randomized controlled trial will be fully remote, enabling data capture from home—where the device is intended to be used.

Mi-Helper has been developed to meet a massive unmet need for effective, targeted, and drug-free pain management of migraines, a condition which impacts 1 billion people worldwide. The small Mi-Helper device delivers a controlled stream of conditioned air with a nebulized mist to the mucosa membranes in the nose, providing relief from migraine-related pain and associated symptoms such as nausea and photosensitivity. The Mi-Helper study features an adaptive design, beginning with the establishment of optimal dosing and culminating in a pivotal trial to determine therapeutic efficacy.

ObvioHealth’s COACH (Clinical Oversight And Coordination Hub) team will remotely monitor patient compliance and safety in near real time. The study will also use ObvioGo app, which 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. By designing a decentralized clinical trial without the need for physical site visits, the two companies hope to recruit patients from anywhere in the continental United States, including underserved communities, and ensure that the device, when launched, can serve a broad population.


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