A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury
Sense Diagnostics, LLC
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. 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.
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 i…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * • 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. Exclusion Cri…
Interventions
- DeviceSENSE device
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.
Locations (6)
- University of FloridaGainesville, Florida
- University of CincinnatiCincinnati, Ohio
- University of PittsburghPittsburgh, Pennsylvania
- MUSCCharleston, South Carolina
- UT HoustonHouston, Texas
- UTSASan Antonio, Texas