Actively Recruiting
A Prospective, Non-randomized, Multi-center Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury and Intracranial Bleeding
Led by Sense Diagnostics, LLC · Updated on 2025-11-25
150
Participants Needed
6
Research Sites
4 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
Researchers are evaluating the SENSE Device, a tool designed to detect traumatic brain injury (TBI) and intracranial bleeding. This phase II, prospective, non-randomized study compares the SENSE Device's performance against the standard diagnostic head CT scan in patients aged 22 and older. The study includes three groups: TBI patients with intracranial bleeding, TBI patients without bleeding, and healthy control subjects. The goal is to understand how well the device detects bleeding and differentiates between these groups. The SENSE Device works by sending a low-powered electromagnetic pulse across the brain and detecting changes that may indicate bleeding or swelling. Participants include 50 TBI patients with bleeding, 50 without bleeding, and 50 healthy controls. All subjects will be monitored with the device for 15 minutes. TBI patients undergo head CT scans, while control subjects are assessed for normal brain health but do not receive imaging. The evaluations involve comparing device results to CT scans and reviewing brain scan images at a core radiology lab. During the study, eligible participants will be monitored with the SENSE Device within 6 hours of their head CT scan and within 24 hours of injury. Researchers will assess the agreement between the device and CT scans in detecting intracranial bleeding. Control subjects will be enrolled based on symptom evaluation and monitored without imaging. The study plans to review primary efficacy outcomes at 12 months, ensuring careful monitoring and data collection throughout the trial period.
CONDITIONS
Brief 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 traumatic brain injury who have had a head CT scan ordered by a treating clinician
- Blood visible on at least 3 consecutive axial CT slices for patients with traumatic intracranial hemorrhage
- Signed informed consent by the participant or legally authorized representative
- Ability and willingness to comply with study procedures
You will not qualify if you...
- Female patients who are pregnant or breastfeeding
- SENSE Device cannot be placed within 6 hours of head CT and within 24 hours of injury
- Open skull fracture
- Presence of metallic intracranial clips, coils, or devices
- Any condition making the patient unsuitable for the study or could affect study results
- Planned intraventricular catheter placement before enrollment
- Planned intracranial surgery before enrollment
- Participation in another medical or surgical interventional clinical trial
- Use of continuous EEG monitoring at enrollment
- Uncertainty about bleeding presence on the enrolling head CT
- Control subjects with history of seizure, stroke, brain tumor, recent concussion, hydrocephalus, brain malformations, structural brain disease, or brain surgery (except benign headaches or old mild concussions over 6 months ago)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 24 hours of injury
Participants with traumatic brain injury undergo a head CT scan to assess for intracranial bleeding as part of standard care. Control subjects undergo symptom evaluation without brain imaging.
1 visit (in-person)
Duration - 15 minutes
Participants are monitored using the SENSE Device for detection of intracranial hemorrhage and cerebral edema.
1 monitoring session
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
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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