Phase II Study Evaluating the SENSE Device to Detect Traumatic Brain Injury Comparing SENSE Device and Head CT in Patients With and Without Intracranial Bleeding Includes Control Subjects With Normal Brain Health

What this Trial Is About

Researchers are evaluating the SENSE Device, a tool designed to detect traumatic brain injury TBI and intracranial bleeding. This phase II, prospective, non-randomized study compares the SENSE Devices performance against the standard diagnostic head CT scan in patients aged 22 and older. The study includes three groups TBI patients with intracranial bleeding, TBI patients without bleeding, and healthy control subjects. The goal is to understand how well the device detects bleeding and differentiates between these groups. The SENSE Device works by sending a low-powered electromagnetic pulse across the brain and detecting changes that may indicate bleeding or swelling. Participants include 50 TBI patients with bleeding, 50 without bleeding, and 50 healthy controls. All subjects will be monitored with the device for 15 minutes. TBI patients undergo head CT scans, while control subjects are assessed for normal brain health but do not receive imaging. The evaluations involve comparing device results to CT scans and reviewing brain scan images at a core radiology lab. During the study, eligible participants will be monitored with the SENSE Device within 6 hours of their head CT scan and within 24 hours of injury. Researchers will assess the agreement between the device and CT scans in detecting intracranial bleeding. Control subjects will be enrolled based on symptom evaluation and monitored without imaging. The study plans to review primary efficacy outcomes at 12 months, ensuring careful monitoring and data collection throughout the trial period.

A Study to Evaluate the SENSE Device's Ability to Detect TBI