HITT Device Pilot Testing for Traumatic Brain Injury

• HITT device (Device): Device scans the fovea of the eye to measure fixation. Patients will then be asked to track the fixation target across an area the size of a playing card, with the device tracking the participant's fixation throughout.

Primary outcomes

• TBI detection [1 day]: Patients who have diagnosed TBI and are admitted to the hospital for treatment will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI

Secondary outcomes

• TBI monitor [14 days]: Patients who have remained in the hospital for TBI and received initial HITT device scan will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI

Sex: All, ages: 18 Years to 40 Years

Inclusion Criteria:

1. Age ≥18-40
2. Documented/ verified mild TBI
3. Mild traumatic brain injury will be defined as Glasgow Coma Scale (GCS) of ≥13 at time of study enrollment
4. Injury occurred < 24 hours ago
5. Positive acute brain CT for clinical care
6. Visual acuity/ hearing adequate for testing
7. Fluency in English or Spanish
8. Ability to provide informed consent
9. Enrolled in TRACK-TBI (IRB #: 825503)

Exclusion Criteria:

1. Catastrophic polytrauma that would interfere with follow-up and outcome assessment
2. Prisoners or patients in custody
3. Pregnancy in female subjects
4. Patients on psychiatric hold (e.g. 5150, 5250)
5. Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessment
6. Major debilitating neurological disease (e.g. stroke, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
7. Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g. substance abuse, alcoholism, HIV/AIDS, major transmittable diseases that may interfere with consent, end-stage cancers, learning disabilities, developmental disorders)
8. Low likelihood of follow-up (e.g. participant or family indicating low interest, homelessness or lack of reliable contacts)
9. Penetrating TBI
10. Spinal cord injury with ASIA (American Spinal Injury Assoc.) score of C or worse
11. Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment.
12. History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
13. Intoxication or chemical impairment at time of examination (upon initial presentation)
14. Evidence on hand-light examination of obvious ocular anomaly or misalignment

• Ramon Diaz-Arrastia, MD, PhD, Principal investigator, University of Pennsylvania