A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury

Completed

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT05155800

Run by

Sense Diagnostics, LLC

People needed

75

Starts

2021-12-28

Expected to finish

2023-11-15

Last updated by the study team

2023-11-22

Who can join

Age: 22 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• Grady — Atlanta, Georgia, United States
• UC Health — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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