Device Digest

Decentralized Clinical Trial for Mi-Helper Device to Revolutionize Migraine Treatment

Mi-Helper, Inc. and ObvioHealth have teamed up 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, allowing patients to use the device from the comfort of their own homes while providing essential data on a real-world population in a real-world setting.

Migraines affect one billion people worldwide, and severe headaches are one of the top causes of emergency room outpatient visits in the United States. Current treatments for migraines are often ineffective, poorly tolerated, and contraindicated for some patients, leading to dissatisfaction among 40% of migraine sufferers according to a recent study.

The small Mi-Helper device delivers a nebulized mist of conditioned air to the mucosa membranes in the nose, providing relief from migraine-related pain and associated symptoms such as nausea and photosensitivity. The trial will feature an adaptive design, beginning with the establishment of optimal dosing and culminating in a pivotal trial to determine therapeutic efficacy.

Patients will use the ObvioGo app to enroll, consent, and report relief of pain and other migraine symptoms, as well as the use of rescue medications and any potential adverse events. ObvioHealth’s COACH team will remotely monitor patient compliance and safety in near real-time.

Recruitment for the study is expected to start this summer.


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