EXPEDITE Study Evaluates Neural Analytics' Portable Transcranial Doppler Technology to Measure Early Strokes
November 13, 2017—Neural Analytics, Inc. announced the results from the first phase of the EXPEDITE program, which demonstrated that the company’s Lucid Transcranial Doppler (TCD) technology platform was accurate with > 94% area under the curve for early measurement of acute ischemic stroke caused by large vessel occlusion (LVO). The data were presented by Thomas Devlin, MD, at the 10th annual Society of Vascular and Interventional Neurology meeting in Boston, Massachusetts.
EXPEDITE was conducted to examine the feasibility of the Lucid TCD ultrasound system in the measurement of cerebral blood flow in patients with LVO. The data demonstrated that the Lucid system is capable of measuring and displaying LVO with 91% sensitivity and 85% specificity as compared to the current standard of care imaging in persons suspected of having a stroke.
The study was composed of 107 patients. Patients were either experiencing acute ischemic stroke caused by LVO of the internal carotid artery or middle cerebral artery as confirmed by CT angiography or were part of a control set of healthy patients. TCD scans in LVO patients were recorded in 30-second intervals across multiple depths for each brain hemisphere while patients were treated with a drug or awaited endovascular or surgical treatment.
The first phase of the EXPEDITE program enrolled patients at Erlanger Southeast Regional Stroke Center in Chattanooga, Tennessee, where Dr. Devlin is Medical Director, and Baptist Stroke & Cerebrovascular Center in Jacksonville, Florida.
Dr. Devlin, who serves as Principal Investigator of the study and Chair of the 2017 Society of Vascular and Interventional Neurology Stroke Workshop, commented in the company's announcement, “The research results of the EXPEDITE program demonstrated that Neural Analytics’ portable diagnostic platform, the Lucid system, has the potential to influence how fast we detect stroke, triage, and treat patients. We are honored to be the first site in the world to evaluate this technology with the goal of improving our stroke patient outcomes.”
Neural Analytics' Lucid system has two key components: a transcranial ultrasound system that is cleared by the US Food and Drug Administration and an investigational automation technology—approved by an investigational review board—designed to simplify data collection for health care practitioners. The device is designed to improve health care management for stroke patients by providing a device to help physicians triage these patients quickly and accurately.
The Lucid system uses TCD ultrasound to assess the brain’s blood vessels from outside the body. The analysis is noninvasive, can be performed in the physician’s office, and helps the physician diagnose brain disorders, potentially without the need for additional, more invasive tests. The system is a battery-operated, medical-grade tablet device.
Neural Analytics’ Lucid M1 system has received US Food and Drug Administration clearance and European CE Mark approval for the monitoring of blood flow velocities in the cerebral vasculature.