A Study to Evaluate the SENSE Device's Ability to Detect TBI

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 in the agreement between the head CT scan and the SENSE Device for detecting intracranial bleeding in patients with TBI? Patients with TBI with intracranial bleeding vs. Patients with TBI without intracranial bleeding (Objective no. 1) Is there a difference in the false positive rate for the presence of bleeding between patients with TBI without intracranial bleeding and control subjects with normal brain health? Patients with TBI without intracranial bleeding vs. control subjects (Objective no. 1) 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 in the agreement between the head CT scan and the SENSE Device for detecting intracranial bleeding in patients with TBI? Patients with TBI with intracranial bleeding vs. Patients with TBI without intracranial bleeding (Objective no. 1) Is there a difference in the false positive rate for the presence of bleeding between patients with TBI without intracranial bleeding and control subjects with normal brain health? Patients with TBI without intracranial bleeding vs. control subjects (Objective no. 1) A separate set of evaluations will be performed, pooling the patients with TBI without intracranial bleeding on initial head CT and the control subjects. The agreements between the SENSE Device and the head CT scan will be compared between these 2 groups: Patients with TBI with intracranial bleeding vs. Subjects without intracranial bleeding (both TBI patients and control subjects). All subjects who meet eligibility criteria should be enrolled. One-hundred (100) patients with TBI (50 with intracranial hemorrhage and 50 without intracranial hemorrhage) will be enrolled to determine whether the SENSE Device can distinguish patients with TBI with intracranial hemorrhage from those without intracranial hemorrhage. Fifty (50) control subjects with normal brain health will be enrolled for comparison to patients with TBI. All subjects will be monitored for 15 minutes with the SENSE Device. Control subjects will not undergo any brain imaging. Control subjects will be enrolled based on symptom evaluation at the time of enrollment. A core radiology lab using independent readers will verify the presence or absence of intracranial hemorrhage and cerebral edema for all scans and will quantify hemorrhage and edema volumes using computer-assisted analysis.