The trials are focused on a device which reportedly provides relief to migraine related pain and other symptoms.
ObvioHealth and Mi-Helper, Inc. announce a partnership 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, enabling data capture from home—where the device is intended to be used.
Mi-Helper has been developed to meet an unmet need for effective, targeted, and drug-free pain management of migraines, a condition which impacts 1 billion people worldwide. Severe headaches are among the top causes of emergency room outpatient visits in the United States. And, in a recent study, 40% of migraine sufferers reported dissatisfaction with current treatments due to lack of efficacy, poor tolerability, and contraindications to common migraine-specific medications.
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The small Mi-Helper 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.
“We are working with the top headache neurologists in the world to inform our clinical studies,” said Steve Schaefer, CEO of Mi-Helper. “We are committed to delivering a paradigm shift for migraine treatment—fast, accessible, and affordable relief for this highly complex and debilitating neurological disease.”
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Medical Device & Technology recently spoke with ObvioHealth's CTO Craig Gravina about the challenges of running clinical trials in digital therapeutic spaces.
"There’s a few challenges specific to running trials in this newly emerging digital therapeutic space," he said. "The challenges of measuring efficacy and adherence in a decentralized clinical trial, it is really the reliance on the patient reported outcomes, and the frequency and adherence to reporting those outcomes. That leads to solutions like remote patient monitoring and devices to measure vitals."