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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: SDx3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TBI patients with intracranial bleeding<br> | Device: SDx3<br>* The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage.<br>|
| TBI patients without intracranial bleeding<br> | Device: SDx3<br>* The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage.<br>|
| Control Subjects with normal brain health<br> | Device: SDx3<br>* The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare ICH in TBI patients to non-ICH control subjects | 1. Distinguish TBI subjects with intracranial hemorrhage from those without intracranial hemorrhage and from non-TBI controls. | up to 12 months | 
| Measure growth of intracranial hemorrhage | 2. Detect new or enlarging intracranial hemorrhage of ≥ 6 ml among TBI subjects, as defined by CT scan. | up to 12 months |