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A Study to Evaluate the SENSE Device's Ability to Detect TBI

RecruitingObservational studyHealthy volunteers welcome

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

Sponsor: Sense Diagnostics, LLC · Participants: 150 · Started: Jul 11, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06828107

Locations in the U.S.

FloridaUniversity of Florida, Gainesville
OhioUniversity of Cincinnati, Cincinnati
PennsylvaniaUniversity of Pittsburgh, Pittsburgh
South CarolinaMUSC, Charleston
TexasUT 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.