Traumatic Brain InjurySense-005NCT05155800
A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Sense Diagnostics, LLC at 2 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 between the ages of 22 to 50 will be enrolled. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- SDx3
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Dec 2021to 15 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- 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 between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14.
Who may be able to join
- Patients who meet all of the following inclusion criteria will be considered candidates for study enrollment:
- Male or female subjects age 22 to 50
- Patients with TBI who have a diagnostic head CT scan within 24 hours of the injury.
- For patients with TBI without intracranial hemorrhage, Glasgow Coma Scale score at enrollment of ≤ 14.
- For patients with TBI, intended clinical monitoring in the hospital setting for at least 6 hours from study enrollment.
- Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian.
- Willingness and ability to comply with schedule for study procedures.
- Control subjects with normal brain health.
Who cannot join
- All subjects meeting any of the following criteria will be excluded from this study:
- Female patients who are pregnant or lactating.
- Known history of seizure or clinical seizure prior to initiating SENSE monitoring.
- Open skull fracture.
- 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.
Show all 12Show fewer
- Planned placement of an intraventricular catheter after the diagnostic (pre-enrollment) CT.
- Planned withdrawal of care within 24 hours of enrollment.
- Planned intracranial surgery within 24 hours of enrollment.
- Current participation in a medical or surgical interventional clinical trial.
- Planned or current use of continuous EEG monitoring.
- Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady
Atlanta, Georgia, 30303
UC Health
Cincinnati, Ohio, 45219
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 and Monitor 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 between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.
- Conditions
- Traumatic Brain Injury
- Being tested
- SDx3
- 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.
SDx3Device
The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| TBI patients with intracranial bleeding | Not described Receives: Device: SDx3 | |
| TBI patients without intracranial bleeding | Not described Receives: Device: SDx3 | |
| Control Subjects with normal brain health | Not described Receives: Device: SDx3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare ICH in TBI patients to non-ICH control subjects
- Distinguish TBI subjects with intracranial hemorrhage from those without intracranial hemorrhage and from non-TBI controls.
Measured: up to 12 months
Measure growth of intracranial hemorrhage
- Detect new or enlarging intracranial hemorrhage of ≥ 6 ml among TBI subjects, as defined by CT scan.
Measured: up to 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 Dec 2021
- Study start28 Dec 2021
- Primary completion17 Oct 2023
- Study completion15 Nov 2023
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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sense Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Ratcliff, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155800
- Sponsor's protocol ID
- Sense-005
- Acronym
- Sense-005
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. 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 and Monitor Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05155800
- Acronym / sponsor ID
- Sense-005 / Sense-005
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sense Diagnostics, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 14 Dec 2021 (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 between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBI patients with intracranial bleeding | – | Device: SDx3 |
| TBI patients without intracranial bleeding | – | Device: SDx3 |
| Control Subjects with normal brain health | – | Device: SDx3 |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14.
Key inclusion criteria (8 listed)
- Patients who meet all of the following inclusion criteria will be considered candidates for study enrollment:
Key exclusion criteria (12 listed)
- All subjects meeting any of the following criteria will be excluded from this study:
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 |
|---|---|---|
| SDx3The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage. | Device | Control Subjects with normal brain health, TBI patients with intracranial bleeding, TBI patients without intracranial bleeding |
Primary outcome
Compare ICH in TBI patients to non-ICH control subjects
Time frame: up to 12 months
1. Distinguish TBI subjects with intracranial hemorrhage from those without intracranial hemorrhage and from non-TBI controls.
Measure growth of intracranial hemorrhage
Time frame: up to 12 months
2. Detect new or enlarging intracranial hemorrhage of ≥ 6 ml among TBI subjects, as defined by CT scan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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. This study is not recruiting at the moment.
Jonathan Ratcliff, MD principal investigator
Emory University
2 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 2 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare ICH in TBI patients to non-ICH control subjects (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 22 Nov 2023.