Early Feasibility Study of a Non-Invasive Device to Estimate Brain Pressure and Cerebral Autoregulation Using the CoMind One EFS

What this Trial Is About

Researchers are evaluating a new non-invasive method to estimate intracranial pressure ICP and assess cerebral autoregulation CAR using the CoMind One EFS device. This observational study aims to develop safer alternatives to the current invasive ICP monitoring, which requires surgery to drill into the skull and carries risks like infection and pain. The study collects extensive data to improve the accuracy of this new technology for patients with conditions such as traumatic brain injury and stroke. Participants who are already receiving invasive ICP and arterial blood pressure ABP monitoring as part of their standard care will have concurrent measurements taken using the CoMind One EFS device. This device records a cerebral blood-flow index non-invasively, and these signals will be analyzed to create and test models estimating ICP without surgery. The study does not involve additional treatments but compares the new devices readings with existing invasive monitors during the observation period. During the study, participants will have simultaneous invasive and non-invasive ICP and ABP measurements recorded until either three weeks after removal of the CoMind device or discharge from the intensive care unit, whichever comes first. Researchers will analyze the data to evaluate the accuracy of the non-invasive device across different skin tones and its ability to detect changes in ICP states and trends. The goal is to gather detailed information to help develop a reliable, non-invasive ICP monitoring system.

CoMind Early Feasibility Study