Recruiting

Observational Study

Sponsor:

Sense Diagnostics, LLC

Code:

NCT06828107

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

SENSE device

Study Details

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

Study ID

NCT06828107

Start date

Jul 11, 2025

Status verified date

Nov, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • • 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 Criteria:

  • • 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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

TBI patients with intracranial bleeding

50 patients with TBI with intracranial bleeding

TBI patients without intracranial bleeding

50 patients with TBI without intracranial bleeding

Control subjects with normal brain health

50 control subjects with normal brain health

Interventions

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.

Primary outcome measure

  • Primary Efficacy Endpoint [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Sara M Keegan, MEd

5133098325skeegan@senseneuro.com

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Hector Meza Comparan, MD

352-273-5550hmezacomparan@ufl.edu

Principal Investigator:

Pouya Ameli, MD

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45209

Contacts

Jason McMullan, MD

513-558-5281mcmulljo@ucmail.uc.edu

Principal Investigator:

Jason McMullan, MD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

Evan Gu

412-735-8498evg16@pitt.edu

Principal Investigator:

David Barton, MD

MUSC

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Paige Hall

843-792-7944hallpai@musc.edu

UT Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Arun Kane

713-500-7813Arun.Kane@uth.tmc.edu

UTSA

Recruiting

San Antonio, Texas, United States, 78249

Contacts

Martha De La Mora

210-450-7956delamora@uthscsa.edu

More Information

Sponsor

Sense Diagnostics, LLC

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Keywords

  • SENSE Device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sense Diagnostics, LLC on 2025-11-25.