MindRhythm's Cranial Accelogram is based on the concept of ballistocardiography discovered in the late 19th century. Ballistocardiography is a measurement of the forces of the cardiac cycle which can have a positional impact on the brain and other organs. These forces have been studied in various capacities leading to scientific advancements for more than 200 years. MindRhythm, and the work of its partnered researchers, is significant and ongoing with some references listed below.
Completed Studies
"EPISODE Detection of hEad Pulse for Ischemic StrOke Verification" Study
This study was comprised of three phases in preparation for FDA submission. A proof of concept phase was followed by Pilot- EPISODE_PS, and Pivotal- EPISODE_VS. This observational, prospective, study collected prehospital HeadPulse readings during stroke assessment to identify and validate the analytical model used to diagnose the presence of large vessel occlusion (LVO) stroke to assist in the prehospital triage decision.
James Paxton, EPISODE research team
Trial Details Available Upon Request
"EPISODE Detection of hEad Pulse for Ischemic StrOke Verification Study" (EPISODE_VS)
This observational, prospective, blinded study collects prehospital HeadPulse readings collected stroke assessment to validate the analytical model used to diagnose the presence of large vessel occlusion (LVO) stroke to assist in prehospital triage.
"Analysis of HeadPulse Biometric Measures Following Concussion in Young Adult Athletes"
A study to characterize temporal changes of HeadPulse, a digital biometric in athletes with sports related concussion.
"EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic" ( EPISODE _PS _COVID )
This observational prospective study documents COVID-19 status on patients seen in the prehospital environment for suspected stroke. HeadPulse readings collected during the encounter will be used to further develop an analytical model used to predict the presence of large vessel occlusion (LVO) stroke to assist in the prehospital triage decision.
"The Neurological Examination Improves Cranial Accelerometry Large Vessel Occlusion Prediction Accuracy"
Designed to compare cranial accelerometry, a device-based approach to large vessel occlusion (LVO) prediction, with neurological examination findings to determine if this improves diagnostic accuracy compared to either alone.
"A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model"
Cranial accelerometry is used to detect cerebral vasospasm and concussion. We Explored this technique in a cohort of code stroke patients to see whether a signature could be identified to aid in the diagnosis of large vessel occlusion (LVO) stroke.
Active Studies
Scheduled Studies
"HeadPulse Large Vessel Occlusion Validation Study"
This observational study is designed to collect HeadPulse recordings from large vessel occlusion patients as confirmed by CTA before they are transferred to the vascular suite for surgery.
"Recording From Normal Subjects Using Harmony" REFRESH
500 "normal" adult subjects with no known brain injury will participate in collecting data that will assist with the optimization of the diagnostic capabilities of the Harmony device in detecting neurologic abnormalities.
"MindRhythm Detection of Athletic Concussion and Recovery Study" DISCOVERY
A prospective, observational study of collegiate athletes who have a suspected diagnosis of concussion. Athletes will collect at home measurements to determine recovery from concussion, symptom inventory and impact of physical activity on neurological health.
Paul A. Lovoi
2024