RecruitingNCT06828107

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

A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury

Sponsor

Sense Diagnostics, LLC

Enrollment

150 participants

Start Date

Jul 11, 2025

Study Type

OBSERVATIONAL

Conditions

Traumatic Brain Injury

Summary

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.

Eligibility

Min Age: 22 Years

Inclusion Criteria5

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 Criteria11

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.

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Interventions

DEVICESENSE device

The SENSE Device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage and/or cerebral edema.