A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury

A Prospective, Non-Randomized, Sequentially Enrolled, Multi-Center, Phase II Study to Evaluate the SENSE Device's Ability to Detect and Monitor 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 between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.

Inclusion Criteria:

• Patients who meet all of the following inclusion criteria will be considered candidates for study enrollment:

  • Male or female subjects age 22 to 50
  • Patients with TBI who have a diagnostic head CT scan within 24 hours of the injury.
  • For patients with TBI without intracranial hemorrhage, Glasgow Coma Scale score at enrollment of ≤ 14.
  • For patients with TBI, intended clinical monitoring in the hospital setting for at least 6 hours from study enrollment.
  • Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian.
  • Willingness and ability to comply with schedule for study procedures.
  • Control subjects with normal brain health.

Exclusion Criteria:

• All subjects meeting any of the following criteria will be excluded from this study:

  • Female patients who are pregnant or lactating.
  • Known history of seizure or clinical seizure prior to initiating SENSE monitoring.
  • Open skull fracture.
  • 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 after the diagnostic (pre-enrollment) CT.
  • Planned withdrawal of care within 24 hours of enrollment.
  • Planned intracranial surgery within 24 hours of enrollment.
  • Current participation in a medical or surgical interventional clinical trial.
  • Planned or current use of continuous EEG monitoring.
  • Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI