Decentralized Clinical Trial to Test Mi-Helper for Migraine Treatment
Mi-Helper, Inc. and ObvioHealth are partnering to conduct a fully remote decentralized clinical trial for a non-invasive neuromodulation device, Mi-Helper. The device provides drug-free pain management for migraines, a condition that impacts one billion people globally. The randomized controlled trial will allow patients to capture data from home, where the device is intended to be used.
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. Traditional treatments for migraines have often been ineffective, leading to dissatisfaction among 40% of migraine sufferers due to lack of efficacy, poor tolerability, and contraindications to common migraine-specific medications.
The decentralized clinical trial 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 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.
