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

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Device: SDx3

• Registration Number: NCT05155800
• Lead Sponsor: Sense Diagnostics, LLC

Brief 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. 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

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-14
• Study Start: 2021-12-28
• Primary Completion: 2023-10-17
• Status Verified: 2023-11
• Study Completion: 2023-11-15
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TBI patients with intracranial bleeding	SDx3	-
TBI patients without intracranial bleeding	SDx3	-
Control Subjects with normal brain health	SDx3	-

Primary Outcome Measures

Name	Time	Method
Compare ICH in TBI patients to non-ICH control subjects	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	up to 12 months	2. Detect new or enlarging intracranial hemorrhage of ≥ 6 ml among TBI subjects, as defined by CT scan.

Trial Locations

Locations (2)

Grady; 🇺🇸 Atlanta, Georgia, United States

UC Health; 🇺🇸 Cincinnati, Ohio, United States