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

Sense Diagnostics, LLC · with Congressionally Directed Medical Research Programs · NCT06828107

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
150
US sites recruiting
6
Study start
July 11, 2025
Record last updated
November 25, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SENSE device

Conditions: Traumatic Brain Injury

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Florida

    Gainesville, FL 32611

    Site contact: Hector Meza Comparan, MD · 352-273-5550 · hmezacomparan@ufl.edu

  • University of Cincinnati

    Cincinnati, OH 45209

    Site contact: Jason McMullan, MD · 513-558-5281 · mcmulljo@ucmail.uc.edu

  • University of Pittsburgh

    Pittsburgh, PA 15260

    Site contact: Evan Gu · 412-735-8498 · evg16@pitt.edu

  • MUSC

    Charleston, SC 29425

    Site contact: Paige Hall · 843-792-7944 · hallpai@musc.edu

  • UT Houston

    Houston, TX 77030

    Site contact: Arun Kane · 713-500-7813 · Arun.Kane@uth.tmc.edu

  • UTSA

    San Antonio, TX 78249

    Site contact: Martha De La Mora · 210-450-7956 · delamora@uthscsa.edu

Study contacts (from the official record)

  • Sara M Keegan, MEd · 5133098325 · skeegan@senseneuro.com
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A Study to Evaluate the SENSE Device's Ability to Detect TBI (NCT06828107) | Bored Studies