SENSE device for detecting brain bleeds after traumatic brain injury

A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury

This research will test whether the SENSE device can detect intracranial bleeding in adults with traumatic brain injury and compare readings to healthy control subjects.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Sense Diagnostics, LLC (Industry-sponsored)
• Locations: 6 sites (Gainesville, Florida and 5 other locations)
• Trial ID: NCT06828107 on ClinicalTrials.gov

What this trial studies

This is a phase II, prospective, non-randomized, multi-center comparison of the SENSE Device versus standard head CT for detecting intracranial hemorrhage. The study enrolls three mutually exclusive groups: TBI patients with intracranial bleeding, TBI patients without bleeding, and control subjects with normal brain health. Adults aged 22 and older who receive a clinical head CT will have the SENSE Device placed within 6 hours of that CT and within 24 hours of injury for TBI patients. Pairwise comparisons will examine agreement between SENSE and CT for detecting bleeding and compare false positive rates between groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 or older with recent TBI who receive a head CT (with device placement within 6 hours of CT and within 24 hours of injury) or healthy control volunteers with normal brain health.

Not a fit: Patients who are pregnant or lactating, have open skull fractures, metallic intracranial devices, or cannot have the SENSE Device placed within the required time windows are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the SENSE device could provide a rapid, non-invasive bedside method to identify intracranial bleeding and speed triage or monitoring decisions.

How similar studies have performed: Prior work on noninvasive devices for detecting intracranial hemorrhage is limited to early-phase and pilot studies, so this phase II effort builds on modest preliminary data rather than widespread proven success.

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.

Where this trial is running

Gainesville, Florida and 5 other locations

• University of Florida — Gainesville, Florida, United States (Recruiting)
• University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
• Musc — Charleston, South Carolina, United States (Recruiting)
• UT Houston — Houston, Texas, United States (Recruiting)
• Utsa — San Antonio, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Jason McMullan, MD — University of Cincinnati
• Study coordinator: Sara M Keegan, MEd

Conditions Traumatic Brain Injury; SENSE Device