The Journal of Stroke: Vascular and Interventional Neurology publishes EPISODE-PS initial trial results
CUPERTINO, Calif. - MindRhythm Inc, in partnership with Wayne State University School of Medicine in Detroit, Michigan, today announces the first publication of results from the hEadPulse for Ischemic StrOke DEtection Prehospital Study (EPISODE-PS) trial.
The EPISODE-PS trial was designed to evaluate the use of MindRhythm’s proprietary Harmony headset technology for identifying large vessel occlusion (LVO) ischemic 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 ischemic strokes even before patients arrive to the hospital. A major and unaddressed challenge in stroke care remains to be the lack of objective and accurate prehospital identification of stroke and stroke type. This decision often results in patient transport to a hospital that lacks detection and treatment capabilities to effectively treat the patient.
Considering the tremendous morbidity and mortality associated with this condition, and the importance of early triage to facilitate appropriate transport for definitive care, the MindRhythm technology could significantly improve the care and outcomes of ischemic stroke patients.
The results released are promising, to “suggest that the Harmony device has a sensitivity and specificity that may be non‐inferior to the LAMS score when tested in an undifferentiated population of suspected stroke patients,” a standard-of-care method for detecting LVO stroke that is commonly used by prehospital and emergency department providers. “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 Society of Vascular and Interventional Neurology (SVIN) annual meeting in Los Angeles, California, by Dr. Wade Smith, MD, PhD. The research was initiated by Dr. Wade Smith from MindRhythm, Inc., including a team of investigators led by the study’s Principal Investigator, Dr. James H. Paxton, MD, an emergency physician, Associate Professor and Director of Clinical Research at Detroit Receiving Hospital / Wayne State University School of Medicine, in Detroit, Michigan.
The blinded, validation portion of the MindRhythm sponsored study, termed EPISODE-VS, has been initiated across 8 regions with approximately 650 EMS workers and is powered to test for superiority with results expected in mid 2023.
MindRhythm, Inc., was founded by John Keane, Dr. Wade Smith MD, PhD, and Dr. Paul Lovoi, PhD, in 2019 as a brain wellness company. The company's initial focus is on optimizing stroke triage in the prehospital setting. MindRhythm’s Harmony device is a novel, non-invasive, diagnostic medical device that can identify a variety of neurological conditions by monitoring a specific waveform found in the brain discovered by MindRhythm. In stroke, the intent is to optimize time to treatment by accurately identifying LVO ischemic stroke in the prehospital environment. To learn more about MindRhythm and the Harmony® headset, visit https://mindrhythm.com.
MindRhythm is a medical technology company focused on preventing neurological injury. Founded by world-renowned scientific experts with significant commercialization success, MindRhythm’s monitoring technology provides real-time visibility to life-threatening situations at home, prehospital, in the operating room, and on the field. MindRhythm’s technology allows clinicians to intervene, optimize and manage care to prevent brain damage. Collaborating with the healthcare community, MindRhythm looks to apply a systematic approach to reducing time to treatment in strokes and monitor neurological health during recovery from injury. Together, let’s save lives and improve the quality of life: https://mindrhythm.com