Decentralized Clinical Trial to Test Revolutionary Migraine Treatment Device
Mi-Helper, a non-invasive neuromodulation device, is set to revolutionize the treatment of migraines, a condition that affects an estimated one billion people worldwide. Developed by Mi-Helper, Inc., the small 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. And now, a pioneering decentralized clinical trial is set to test its efficacy.
In partnership with ObvioHealth, the randomized controlled trial will be fully remote, enabling patients to capture data from home where the device is intended to be used. This approach is a game-changer for patients who have struggled with traditional treatments that are often ineffective, leading to dissatisfaction among 40% of migraine sufferers due to lack of efficacy, poor tolerability, and contraindications to common migraine-specific medications.
The study features an adaptive design, starting with establishing optimal dosing and culminating in a pivotal trial to determine therapeutic efficacy. Patients will use the ObvioGo app to remotely enroll, consent, and report relief of pain and other migraine symptoms, as well as track the use of rescue medications and any potential adverse events. The ObvioHealth’s COACH team will remotely monitor patient compliance and safety in near real-time.
“We are working with the top headache neurologists in the world to inform our clinical studies,” said Steve Schaefer, CEO of Mi-Helper. “We are committed to delivering a paradigm shift for migraine treatment—fast, accessible, and affordable relief for this highly complex and debilitating neurological disease.”
The study is expected to begin recruiting patients this summer from anywhere in the continental United States, including underserved communities, ensuring the device can serve a broad population. This decentralized clinical trial is a promising step forward in the search for effective, drug-free treatments for migraines, and could provide much-needed relief for those who suffer from this debilitating condition.