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A Study to Evaluate the SENSE Device for Detecting Traumatic Brain Injury

This study is testing a new device called SENSE to see if it can detect problems like bleeding inside the brain (intracranial hemorrhage) or swelling (cerebral edema) after a traumatic brain injury (TBI). The SENSE device sends a low-power signal through your brain and looks for changes that might indicate these issues. We are comparing the SENSE device's results to standard CT scans. We are looking for adults aged 22 and older who have had a TBI, with or without bleeding, or healthy volunteers. The study aims to enroll 150 people. The current status of the study is unclear, meaning it might be actively recruiting or paused.

Study design
This is an observational study that will enroll 150 adults aged 22 and older. It compares the SENSE device to CT scans in patients with TBI and healthy individuals.
What's involved
If you have a TBI, you would be monitored with the SENSE Device within 6 hours of a CT scan and within 24 hours of your injury.
Compensation
Not stated in the trial record.
Follow-up
The primary efficacy endpoint, which measures how well the device works, will be assessed at 12 months.

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NCT06828107

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

Recruiting
Not specifiedAges 22+Observational
Sense Diagnostics, LLC
~150 participants
Updated 2025-11-25 on ClinicalTrials.gov
What's tested:SENSE device

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Efficacy Endpoint
Measured over 12 months

Conditions

Traumatic Brain Injury

Explore related trials

HealthyTraumatic Encephalopathy

Where it's being run

6 sites across 5 states
Texas2
Florida1
Ohio1
Pennsylvania1
South Carolina1

Study leadership

  • Jason McMullan, MD · PRINCIPAL_INVESTIGATOR · University of Cincinnati

Who to contact

Sara M Keegan, MEd
[email protected]
5133098325
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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

• 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.

What this trial measures

  • Primary Efficacy Endpoint12 months

    The SENSE output for each patient will be classified as showing intracranial hemorrhage or no intracranial hemorrhage for each study CT with corresponding SENSE data. The SENSE output will be compared with the gold standard (CT scan result) to determine the accuracy of the SENSE Device as classifying TBI patients with and without intracranial hemorrhage correctly.