NCT06828107 · Sense Diagnostics, LLC
A Study to Evaluate the SENSE Device's Ability to Detect TBI
(SENSE-007)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Gainesville, Florida
- Cincinnati, Ohio
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
- Houston, Texas
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 25, 2025 · Source of record for eligibility and locations