New brain scanner could spot bleeding in minutes without radiation
NCT ID NCT06828107
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device called SENSE that uses low-power electromagnetic pulses to check for bleeding or swelling in the brain after a traumatic injury. Researchers will compare the device's results to standard CT scans in 150 adults, including those with and without brain injuries, as well as healthy volunteers. If accurate, the device could offer a faster, bedside way to diagnose brain bleeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SENSE device (electromagnetic pulse device)
- What this could lead to
- If successful, this could provide a faster, portable way to detect brain bleeding after head injury, potentially speeding up diagnosis and treatment.
- What could go wrong
- This is an early-phase study with only 150 participants, so results may not apply to all patients. The device is compared to CT scans, which are the current standard, and may not be as accurate.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MUSC
RECRUITINGCharleston, South Carolina, 29425, United States
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UT Houston
RECRUITINGHouston, Texas, 77030, United States
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UTSA
RECRUITINGSan Antonio, Texas, 78249, United States
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University of Cincinnati
RECRUITINGCincinnati, Ohio, 45209, United States
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University of Florida
RECRUITINGGainesville, Florida, 32611, United States
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University of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15260, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a web program rebuild memory after brain injury?
- Why a simple fall can cause brain bleeding in older adults
- Bedside ultrasound could flag hidden brain injury decline
- Zapping the brain to restore lost vision
- Machine learning may forecast brain decline after head injury
- MRI tracer could expose hidden brain energy crisis after head injury