NCT06828107 A Study to Evaluate the SENSE Device's Ability to Detect TBI
| NCT ID | NCT06828107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sense Diagnostics, LLC |
| Condition | Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-07-11 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jason McMullan, MD
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT06828107 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06828107 currently recruiting?
Yes, NCT06828107 is actively recruiting participants. Contact the research team at skeegan@senseneuro.com for enrollment information.
Where is the NCT06828107 trial being conducted?
This trial is being conducted at Gainesville, United States, Cincinnati, United States, Pittsburgh, United States, Charleston, United States and 2 additional locations.
Who is sponsoring the NCT06828107 clinical trial?
NCT06828107 is sponsored by Sense Diagnostics, LLC. The principal investigator is Jason McMullan, MD at University of Cincinnati. The trial plans to enroll 150 participants.