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

NCT06828107 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-11-25

No results posted yet for this study

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

Interventions

DEVICE

SENSE 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.

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Sense Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Jason McMullan, MD · University of Cincinnati

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2026-05-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828107 on ClinicalTrials.gov