MindRhythm, in partnership with Wayne State University School of Medicine (Detroit, USA), has announced the first publication of results from its EPISODE-PS trial in the journal Stroke: Vascular and Interventional Neurology.
The EPISODE-PS trial was designed to evaluate the use of MindRhythm’s proprietary Harmony headset technology for identifying large vessel occlusion (LVO) ischaemic strokes in the prehospital setting.
It is believed that the EPISODE-PS study is the first stroke device study to target patients in the prehospital environment, testing the theory that this device can detect LVO ischaemic strokes even before patients arrive to the hospital, a company press release notes. Considering the “tremendous morbidity and mortality” associated with stroke, and the importance of early triage to facilitate appropriate transport for definitive care, MindRhythm claims its technology could “significantly improve the care and outcomes of ischaemic stroke patients”.
The results released are promising, as they “suggest that the Harmony device has a sensitivity and specificity that may be non‐inferior to the LAMS [Los Angeles motor scale] score when tested in an undifferentiated population of suspected stroke patients”. MindRhythm’s recent release also notes that, as per EPISODE-PS findings, “the use of a non‐invasive device to detect LVO has substantial implications for prehospital LVO stroke management, including the potential for improved triage and improved outcomes for patients with LVO stroke, without delaying care for non‐LVO stroke patients”.
The pilot data were first presented at the 2022 Society of Vascular and Interventional Neurology (SVIN) annual meeting (16–19 November, Los Angeles, USA) by Wade Smith—MindRhythm co-founder and chair of the scientific advisory board. The research was initiated by Smith and a team of investigators led by the study’s principal investigator, James Paxton (Detroit Receiving Hospital/Wayne State University School of Medicine, Detroit, USA).
The blinded, validation portion of the MindRhythm-sponsored study, termed EPISODE-VS, has been initiated across eight regions with approximately 650 emergency medical services (EMS) workers and is powered to test for superiority, with results expected in mid-2023.
