MindRhythm has announced that results from the pilot phase of its three-phase clinical study, EPISODE, have been published in Academic Emergency Medicine. While pilot EPISODE data have been presented in various academic society forums, this is the first official publication of results from the study, according to a press release from the company.
The company claims that its family of EPISODE studies, assessing MindRhythm’s Harmony technology in the prehospital detection of ischaemic stroke, is the largest evaluation of a prehospital stroke device, with eight geographies, 17 hospitals and 14 emergency medical services (EMS) groups participating in this research.
Results from the EPISODE-PS-COVID pilot phase reveal that Harmony—a cranial accelerometery-based device—is a feasible tool for use in the EMS-prehospital setting, and can reliably identify large vessel occlusion (LVO) stroke based on ‘headpulse’ measurements. Use of the device algorithm incorporating subjective data from the commonly used Los Angeles motor scale (LAMS), and Harmony’s cranial accelerometery data, resulted in “significantly higher sensitivity without reduced specificity when compared to the use of LAMS alone”.
MindRhythm’s recent press release notes that the goal of effectively identifying LVO stroke at the prehospital stage is to improve triage decisions, and this knowledge ensures a critical patient arrives at the hospital equipped with the proper treatment tools—which is the difference between life, death, and disability. In addition, data suggest that, currently, 70–75% of LVO patients are triaged to the wrong hospital. Another challenge arises from the fact that the standard prehospital method of identifying a stroke type is a subjective assessment of symptoms plugged into various scales and scores.
MindRhythm’s diagnostic tool is designed to improve outcomes by ensuring that, at the start of care, and in the prehospital setting, the best triage-to-treatment decision for the patient is made based on the type of stroke they have suffered.
The company was granted a Breakthrough Device designation by the US Food and Drug Administration (FDA) as a result of the data from EPISODE-PS-COVID, and combined datasets from the pilot and pivotal phases of the ultimate EPISODE study will be used for MindRhythm’s FDA submission.
Primary Investigator James Paxton (Wayne State Medical, Detroit, USA) is leading this research with the support of 18 sub-investigators throughout the country. Paxton submitted the manuscript to the journal Academic Emergency Medicine, highlighting the results of pilot study EPISODE-PS-COVID, on behalf of the entire research team. The abstract for this publication was awarded ‘Best Overall Abstract’ in October of 2023 by the American College of Emergency Physicians (ACEP) Research Committee.
