Actively Recruiting
A Study to Evaluate the SENSE Device's Ability to Detect TBI
Led by Sense Diagnostics, LLC · Updated on 2025-11-25
150
Participants Needed
6
Research Sites
50 weeks
Total Duration
On this page
Sponsors
S
Sense Diagnostics, LLC
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
A Study to Evaluate the SENSE Device's Ability to Detect TBI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or more 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
You will not qualify if you...
- Female patients who are pregnant or lactating
- SENSE Device cannot be placed within 6 hours of a standard head CT and within 24 hours of injury
- Open skull fracture (closed skull fracture is allowed)
- Metallic intracranial clip, coil, or device (such as metallic ICP monitor)
- Any condition or finding that makes patient unsuitable for SENSE Device monitoring or participation
- Planned placement of an intraventricular catheter before enrollment
- Planned intracranial surgery before enrollment
- Current participation in a medical or surgical interventional clinical trial
- Use of continuous EEG monitoring at enrollment
- Clinical uncertainty about presence or absence of hemorrhage on enrolling head CT
- Control subjects must have no history of seizure, stroke, brain tumor, TBI requiring emergency evaluation, concussion within 6 months, hydrocephalus, intracranial vascular malformation, other structural brain disease, or intracranial surgery
- Benign headache disorders and mild concussion more than 6 months prior are allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
2
University of Cincinnati
Cincinnati, Ohio, United States, 45209
Actively Recruiting
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Actively Recruiting
4
MUSC
Charleston, South Carolina, United States, 29425
Actively Recruiting
5
UT Houston
Houston, Texas, United States, 77030
Actively Recruiting
6
UTSA
San Antonio, Texas, United States, 78249
Actively Recruiting
Research Team
S
Sara M Keegan, MEd
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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