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A Study to Evaluate the SENSE Device's Ability to Detect TBI
A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury
Who can join
Ages 22 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * • 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. Exclusion Criteria: * • 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.
About the study
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.
What is being tested
- SENSE device (device)
Sponsor: Sense Diagnostics, LLC · Participants: 150 · Started: Jul 11, 2025
Contact the study team
- Sara M Keegan, MEd · Phone: 5133098325
Official record on ClinicalTrials.gov — NCT06828107
Locations in the U.S.
| Florida | University of Florida, Gainesville |
| Ohio | University of Cincinnati, Cincinnati |
| Pennsylvania | University of Pittsburgh, Pittsburgh |
| South Carolina | MUSC, Charleston |
| Texas | UT Houston, Houston UTSA, San Antonio |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.