HITT Device Pilot Testing for Traumatic Brain Injury
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 8/31/2018 |
| Start Date: | August 22, 2017 |
| End Date: | February 28, 2018 |
Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
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.
(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.
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
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