Status:
COMPLETED
HITT Device Pilot Testing for Traumatic Brain Injury
Lead Sponsor:
Rebiscan, Inc.
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The purpose of this research study is to collect data from the eyes of traumatic brain injury (TBI) patients. Patients will look at a green target that will measure the fixation of the eye for 30 seco...
Eligibility Criteria
Inclusion
- Age ≥18-40
- Documented/ verified mild TBI
- Mild traumatic brain injury will be defined as Glasgow Coma Scale (GCS) of ≥13 at time of study enrollment
- Injury occurred \< 24 hours ago
- Positive acute brain CT for clinical care
- Visual acuity/ hearing adequate for testing
- Fluency in English or Spanish
- Ability to provide informed consent
- Enrolled in TRACK-TBI (IRB #: 825503)
Exclusion
- Catastrophic polytrauma that would interfere with follow-up and outcome assessment
- Prisoners or patients in custody
- Pregnancy in female subjects
- Patients on psychiatric hold (e.g. 5150, 5250)
- Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessment
- Major debilitating neurological disease (e.g. stroke, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
- 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)
- Low likelihood of follow-up (e.g. participant or family indicating low interest, homelessness or lack of reliable contacts)
- Penetrating TBI
- Spinal cord injury with ASIA (American Spinal Injury Assoc.) score of C or worse
- 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.
- History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
- Intoxication or chemical impairment at time of examination (upon initial presentation)
- Evidence on hand-light examination of obvious ocular anomaly or misalignment
Key Trial Info
Start Date :
August 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03249818
Start Date
August 22 2017
End Date
February 28 2018
Last Update
August 29 2018
Active Locations (1)
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1
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104