Observational study of the SENSE device to detect bleeding inside the skull after traumatic brain injury

You may qualify if

• 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.

You can't join if

• Female patients who are pregnant or lactating.
• SENSE Device is unable to be placed within 6 hours of a standard of care head CT and within 24 hours of injury.
• Open skull fracture (closed skull fracture is not an exclusion).
• Metallic intracranial clip, coil, or device (such as metallic ICP monitor).
• Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE Device monitoring or study participation or may confound the outcome of the study.
• Planned placement of an intraventricular catheter prior to study enrollment.
• Planned intracranial surgery prior to study enrollment.
• Current participation in a medical or surgical interventional clinical trial.
• Use of continuous EEG monitoring at the time of enrollment.
• Clinical uncertainty about the presence or absence of hemorrhage on the enrolling head CT.
• Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI requiring emergency room evaluation, concussion within the previous 6 months, hydrocephalus, intracranial vascular malformation, other structural brain disease, or intracranial surgery. Benign headache disorders (e.g. migraine headache, tension headache), and mild concussion > 6 months prior to enrollment are not exclusions.