SENSE device for detecting brain bleeds after traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: skeegan@senseneuro.com
• Phone: 5133098325

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.