HITT Device Pilot Testing for Traumatic Brain Injury

Completed · Not applicable

Conditions studied: Brain Injuries, Traumatic

In brief

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.

Key facts

Study ID

NCT03249818

Run by

Rebiscan, Inc.

People needed

7

Starts

2017-08-22

Expected to finish

2018-02-28

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.