Mi-Helper, Inc. has partnered with ObvioHealth to conduct a groundbreaking decentralized clinical trial for their non-invasive neuromodulation device for the treatment of migraines. The randomized controlled trial will be fully remote, allowing patients to use the device from home, providing a real-world population with essential data in a real-world setting.
Migraines affect one billion people worldwide, with severe headaches being one of the leading causes of emergency room outpatient visits in the United States. Current treatments for migraines 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 Mi-Helper device is designed to meet this massive unmet need for effective, targeted, and drug-free pain management of migraines. The 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 clinical trial features an adaptive design, beginning with the establishment of optimal dosing and culminating in a pivotal trial to determine therapeutic efficacy. Patients will enroll, consent, and report relief of pain and other migraine symptoms using the ObvioGo app. The app will also track the use of rescue medications and any potential adverse events. ObvioHealth’s COACH team will monitor patient compliance and safety in near real-time.
The study will recruit patients from anywhere in the continental United States, including underserved communities, ensuring that the device, when launched, can serve a broad population. Recruitment is expected to begin this summer.