Traumatic Brain InjurySENSE-007NCT06828107
A Study to Evaluate the SENSE Device's Ability to Detect TBI
An observational study of Traumatic Brain Injury, run by Sense Diagnostics, LLC at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- SENSE device
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Jul 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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 may be able to join
- • 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.
Who cannot join
- • 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
MUSC
Charleston, South Carolina, 29425
Paige Hall, 843-792-7944, hallpai@musc.edu
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45209
Jason McMullan, MD, 513-558-5281, mcmulljo@ucmail.uc.edu
Jason McMullan, MD
- Recruiting
University of Florida
Gainesville, Florida, 32611
Hector Meza Comparan, MD, 352-273-5550, hmezacomparan@ufl.edu
Pouya Ameli, MD
- Recruiting
UT Houston
Houston, Texas, 77030
Arun Kane, 713-500-7813, Arun.Kane@uth.tmc.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Evan Gu, 412-735-8498, evg16@pitt.edu
David Barton, MD
- Recruiting
UTSA
San Antonio, Texas, 78249
Martha De La Mora, 210-450-7956, delamora@uthscsa.edu
About this study
Official title: A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury
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.
Read the 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
- Being tested
- SENSE device
- Keywords
- SENSE Device
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSE deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TBI patients with intracranial bleeding | 50 patients with TBI with intracranial bleeding Receives: Device: SENSE device | |
| TBI patients without intracranial bleeding | 50 patients with TBI without intracranial bleeding Receives: Device: SENSE device | |
| Control subjects with normal brain health | 50 control subjects with normal brain health Receives: Device: SENSE device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
The SENSE output for each patient will be classified as showing intracranial hemorrhage or no intracranial hemorrhage for each study CT with corresponding SENSE data. The SENSE output will be compared with the gold standard (CT scan result) to determine the accuracy of the SENSE Device as classifying TBI patients with and without intracranial hemorrhage correctly.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start11 Jul 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sense Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Jason McMullan, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828107
- Sponsor's protocol ID
- SENSE-007
- Other IDs
- TP230368
- Acronym
- SENSE-007
- Status last verified
- Nov 2025
- First submitted
- 10 Feb 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We have not made a determination yet as a company
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06828107
- Acronym / sponsor ID
- SENSE-007 / SENSE-007
- Conditions
- Traumatic Brain Injury
- Keywords
- SENSE Device
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sense Diagnostics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBI patients with intracranial bleeding | – | Device: SENSE device50 patients with TBI with intracranial bleeding |
| TBI patients without intracranial bleeding | – | Device: SENSE device50 patients with TBI without intracranial bleeding |
| Control subjects with normal brain health | – | Device: SENSE device50 control subjects with normal brain health |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- • Male or female adults age 22 and older
Key exclusion criteria (11 listed)
- • Female patients who are pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENSE deviceThe 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. | Device | Control subjects with normal brain health, TBI patients with intracranial bleeding, TBI patients without intracranial bleeding |
Primary outcome
Primary Efficacy Endpoint
Time frame: 12 months
The SENSE output for each patient will be classified as showing intracranial hemorrhage or no intracranial hemorrhage for each study CT with corresponding SENSE data. The SENSE output will be compared with the gold standard (CT scan result) to determine the accuracy of the SENSE Device as classifying TBI patients with and without intracranial hemorrhage correctly.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided. We have not made a determination yet as a company
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason McMullan, MD principal investigator
University of Cincinnati
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Sense Diagnostics, LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara M Keegan, MEd (5133098325, skeegan@senseneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.