Mi-Helper, Inc. and ObvioHealth have teamed up to conduct a pioneering decentralized clinical trial for their innovative non-invasive neuromodulation device. The device, Mi-Helper, is designed to provide targeted, drug-free pain management for migraines, a debilitating neurological disease that affects one billion people worldwide.
Unlike traditional clinical trials, which require patients to visit physical sites, the fully remote trial allows patients to use the device from the comfort of their own home, providing data in a real-world setting. The study features an adaptive design that begins with establishing optimal dosing and culminates in a pivotal trial to determine therapeutic efficacy. The ObvioGo app enables patients to 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.
Mi-Helper 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 device’s effectiveness is crucial in addressing the unmet need for effective, targeted, and drug-free pain management of migraines. Traditional treatments have proven 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 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. By designing a decentralized clinical trial, Mi-Helper and ObvioHealth are dedicated to inclusivity and providing fast, accessible, and affordable relief for this highly complex and debilitating neurological disease.