A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury
NCT ID: NCT05155800
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2021-12-28
2023-11-15
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TBI patients with intracranial bleeding
SDx3
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.
TBI patients without intracranial bleeding
SDx3
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.
Control Subjects with normal brain health
SDx3
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.
Interventions
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SDx3
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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
22 Years
50 Years
ALL
Yes
Sponsors
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Sense Diagnostics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Ratcliff, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady
Atlanta, Georgia, United States
UC Health
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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Sense-005
Identifier Type: -
Identifier Source: org_study_id