In an article published by EMS World back in June of 2021, it was postulated that MindRhythm’s rapid, disposable, noninvasive Harmony headset could detect Large Vessel Occlusion strokes in the field. At the time, MindRhythm had preliminary, hospital-based data suggesting the device could accurately identify LVO strokes. However, the company felt strongly that it was important to engage in a prehospital trial to demonstrate efficacy in the arena in which the device would be used. Since that time, MindRhythm has partnered with EMS facilities in multiple states as well as their respective receiving hospitals to collect initial data to support its hypotheses that the Harmony headset could effectively, accurately, and objectively, identify Large Vessel Occlusion (LVO) stroke. The results from the first phase of the EPISODE trial, hEadPulse for Ischemic StrOke DEtection Prehospital Study (EPISODE-PS) demonstrated that Harmony can objectively identify LVO stroke at a high degree of sensitivity (78%) and specificity (99%), making it a valuable addition to stroke assessment. These preliminary results were presented at SVIN in November of 2022 and the full manuscript will be published in an emergency medicine journal shortly.
The primary objective of the EPISODE-PS trial was to demonstrate the performance of the Harmony headset relative to CT Angiography (CTA) as ground truth following a patient scan at the hospital. Medics, when suspecting stroke, would perform a stroke scale and place the device on the patient’s head to collect a HeadPulseä reading in under 90 seconds. (The HeadPulse, discovered by MindRhythm, is a unique cranial biometric signal that results from the systolic force of blood to the brain. Changes in this signal act as the diagnostic feature that determines the presence of a large vessel occlusion). The readout was blinded to the medics during the study and captured on the device software. Once the patient was delivered to the hospital, the device was dropped off with the study coordinator, and all patient information was entered in Redcap. The device reading was compared to an adjudicated CT for the final determination of performance following consent from the patient or family.
The Episode Part 1 trial had the additional goal of developing a final version of the device based on real-world use, that would be clinically viable and therefore embraced by EMS professionals. Early versions of the device encountered challenges in the field, such as patient motion, that are easier to mitigate once the patient is at the hospital. MindRhythm took the input, both formal and informal, from the study team to finalize the device design, improve the ergonomics and optimize device performance. The result is a robust platform designed with significant input from primary users and tailored according to their needs in the field. The final step before FDA submission is to replicate the success of part one with a blinded, FDA protocol that is currently underway.
Originally based out of Wayne State Hospital in Detroit Michigan, over the past 18 months, the trial has expanded to include 16 hospitals in Michigan, California, Indiana, Florida, and Utah that will be participating in the final portion of the study. The benefits of expanding the study footprint were primarily accelerating enrollments and enhancing the geographic and demographic patient capture. However, it is interesting to note that the primary driver in expansion was inbound interest from the various hospitals and EMS facilities. As word about the study got out, EMS groups and emergency directors approached the company about participating. This clearly demonstrates awareness of the challenges in LVO triage and a desire for a product of this type to aid in triage efforts. As a result, EPISODE Part 1 turned out to be one of the largest prehospital medical device trials, having enrolled approximately 600 patients in the preliminary portion. Based on the final trial design, it is expected the study will enroll another 200-250 patients in the blinded portion of the trial. The results of both phases will be included in the FDA submission of the Harmony headset in the fall of 2023.
Once cleared for use by the FDA in the coming months, MindRhythm intends to aid in prehospital triage to the benefit of all stroke patients, though the company recognizes that its role is primarily providing a tool for EMS. Real change will be driven primarily by the EMS community that can use an objective device in conjunction with their clinical assessment to better identify LVO patients who are candidates for direct dispatch to a thrombectomy-capable hospital. Dr. James Paxton, an emergency medicine specialist, and the PI of the study, after witnessing the function and results of the device stated: “Time lost is brain lost, and delays can lead to devastating injuries that may never heal. This technology is going to change lives.” Widespread and swift acceptance of MindRhythm’s technology in all sectors of the care continuum could immediately begin saving lives by optimizing triage decisions, readying stroke teams, increasing efficiencies, and improving access to lifesaving treatments.
See the original article on EMS World’s website