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

NCT06828107 | Recruiting FDA Device

• 2 other identifiers: SENSE-007TP230368
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

SENSE Device

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint

  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.

  12 months

Study Arms (3)

TBI patients with intracranial bleeding

50 patients with TBI with intracranial bleeding

Device: SENSE device

TBI patients without intracranial bleeding

50 patients with TBI without intracranial bleeding

Device: SENSE device

Control subjects with normal brain health

50 control subjects with normal brain health

Device: SENSE device

Interventions

SENSE device 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.

Control subjects with normal brain health; TBI patients with intracranial bleeding; TBI patients without intracranial bleeding

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sense Diagnostics, LLC: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (6)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45209, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

MUSC

Charleston, South Carolina, 29425, United States

RECRUITING

UT Houston

Houston, Texas, 77030, United States

RECRUITING

UTSA

San Antonio, Texas, 78249, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jason McMullan, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara M Keegan, MEd

CONTACT

5133098325; skeegan@senseneuro.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (6)