A Study to Evaluate the SENSE Device's Ability to Detect TBI
Sense Diagnostics, LLC · with Congressionally Directed Medical Research Programs · NCT06828107
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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