ObvioHealth has partnered with Mi-Helper to carry out a decentralised clinical study for the latter’s non-invasive neuromodulation device to treat migraines.
The randomised controlled study will be conducted remotely to facilitate the capturing of data from home settings.
The Mi-Helper device is said to be developed to deliver effective, targeted and drug-free pain management for migraines, a condition that affects one billion people across the world.
According to the company, the small Mi-Helper device offers a controlled stream of conditioned air with a nebulised mist to the mucosa membranes in the nose.
It helps provide relief from migraine-related pain and associated symptoms, such as nausea and photosensitivity.
Mi-Helper CEO Steve Schaefer said: “We are working with the top headache neurologists in the world to inform our clinical studies.
“And, we are committed to delivering a paradigm shift for migraine treatment – fast, accessible and affordable relief for this highly complex and debilitating neurological disease.”
Featuring an adaptive design, the trial is anticipated to begin enrolment this summer.
With the ObvioGo app, patients will be able to remotely enrol, consent and report relief of pain and other migraine symptoms, as well as the use of rescue medications or any potential adverse events.
ObvioHealth’s clinical oversight and coordination hub (COACH) team will be responsible for the remote monitoring of patient compliance and safety in near real time.
ObvioHealth CEO Ivan Jarry said: “By designing a decentralised clinical trial without the need for physical site visits, we can recruit patients anywhere in the continental United States, including underserved communities.
“This will provide Mi-Helper with essential data on a real-world population in a real-world setting and should help to ensure that the device, when launched, can serve a broad population.”