A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury
The study population will consist of 3 mutually-exclusive sets of patients and subjects: * TBI patients with intracranial bleeding * TBI patients without intracranial bleeding * Control subjects with normal brain health. Research subjects ages 22 and older will be enrolled. All TBI patients must be monitored with the SENSE Device within 6 hours of a diagnostic head CT scan ordered by a treating clinician and within 24 hours of injury.
• • Male or female adults age 22 and older
‣ Patients with TBI who have a head CT scan obtained in the mobile stroke unit, emergency department, or hospital, ordered by a treating clinician OR control subjects with normal brain health.
⁃ For patients with traumatic intracranial hemorrhage, blood is visible on ≥ 3 consecutive axial CT slices.
⁃ Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legally authorized representative.
⁃ Willingness and ability to comply with schedule for study procedures.