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

NCT ID: NCT06828107

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-11
• Study Completion Date: 2026-06-30

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.

Detailed Description

This study is a phase II, prospective, non-randomized, multi-center, within patient and between-group comparison of the SENSE Device and the standard diagnostic test, head CT scan, in patients with a diagnosis of TBI with or without intracranial bleeding (defined as epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, and/or traumatic contusions/intraparenchymal hemorrhage) and subjects with normal brain health for the detection of intracranial hemorrhages.

The following pair-wise comparisons will be performed to address the following research questions:

Is there a difference in the agreement between the head CT scan and the SENSE Device for detecting intracranial bleeding in patients with TBI? Patients with TBI with intracranial bleeding vs. Patients with TBI without intracranial bleeding (Objective no. 1)

Is there a difference in the false positive rate for the presence of bleeding between patients with TBI without intracranial bleeding and control subjects with normal brain health? Patients with TBI without intracranial bleeding vs. control subjects (Objective no. 1)

This study is a phase II, prospective, non-randomized, multi-center, within patient and between-group comparison of the SENSE Device and the standard diagnostic test, head CT scan, in patients with a diagnosis of TBI with or without intracranial bleeding (defined as epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, and/or traumatic contusions/intraparenchymal hemorrhage) and subjects with normal brain health for the detection of intracranial hemorrhages.

The following pair-wise comparisons will be performed to address the following research questions:

Is there a difference in the agreement between the head CT scan and the SENSE Device for detecting intracranial bleeding in patients with TBI? Patients with TBI with intracranial bleeding vs. Patients with TBI without intracranial bleeding (Objective no. 1)

Is there a difference in the false positive rate for the presence of bleeding between patients with TBI without intracranial bleeding and control subjects with normal brain health? Patients with TBI without intracranial bleeding vs. control subjects (Objective no. 1)

A separate set of evaluations will be performed, pooling the patients with TBI without intracranial bleeding on initial head CT and the control subjects. The agreements between the SENSE Device and the head CT scan will be compared between these 2 groups:

Patients with TBI with intracranial bleeding vs. Subjects without intracranial bleeding (both TBI patients and control subjects).

All subjects who meet eligibility criteria should be enrolled. One-hundred (100) patients with TBI (50 with intracranial hemorrhage and 50 without intracranial hemorrhage) will be enrolled to determine whether the SENSE Device can distinguish patients with TBI with intracranial hemorrhage from those without intracranial hemorrhage. Fifty (50) control subjects with normal brain health will be enrolled for comparison to patients with TBI. All subjects will be monitored for 15 minutes with the SENSE Device. Control subjects will not undergo any brain imaging. Control subjects will be enrolled based on symptom evaluation at the time of enrollment.

A core radiology lab using independent readers will verify the presence or absence of intracranial hemorrhage and cerebral edema for all scans and will quantify hemorrhage and edema volumes using computer-assisted analysis.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TBI patients with intracranial bleeding

50 patients with TBI with intracranial bleeding

SENSE device

Intervention Type: 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.

TBI patients without intracranial bleeding

50 patients with TBI without intracranial bleeding

SENSE device

Intervention Type: 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

50 control subjects with normal brain health

SENSE device

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Sense Diagnostics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason McMullan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status: RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

MUSC

Charleston, South Carolina, United States

Site Status: RECRUITING

UT Houston

Houston, Texas, United States

Site Status: RECRUITING

UTSA

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara M Keegan, MEd

Role: CONTACT

skeegan@senseneuro.com

5133098325

Facility Contacts

Hector Meza Comparan, MD

Role: primary

hmezacomparan@ufl.edu

352-273-5550

Jason McMullan, MD

Role: primary

mcmulljo@ucmail.uc.edu

513-558-5281

Evan Gu

Role: primary

evg16@pitt.edu

412-735-8498

Paige Hall

Role: primary

hallpai@musc.edu

843-792-7944

Arun Kane

Role: primary

Arun.Kane@uth.tmc.edu

713-500-7813

Martha De La Mora

Role: primary

delamora@uthscsa.edu

210-450-7956

Other Identifiers

TP230368

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SENSE-007

Identifier Type: -

Identifier Source: org_study_id