Clinical trial NCT03249818: HITT Device Pilot Testing for Traumatic Brain Injury
Official title: Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Lead sponsor: Rebiscan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
First posted: 2017-08-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: TBI detection
timeFrame: 1 day
Secondary outcomes:
measure: TBI monitor
timeFrame: 14 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ramon Diaz-Arrastia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: