Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injuries, Traumatic
- Sponsor
- Rebiscan, Inc.
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- TBI detection
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 seconds. In that 30 seconds, the location of the green target will change and the participant is to track, with their eyes, the light as best they can. The device will measure how well fixation was maintained and the speed of the saccadic movements of the eye. Data will then be used to determine whether there is correlation between these measures and known TBI.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
TBI detection
Time Frame: 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)