Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients

Completed

Conditions studied: Brain Concussion, Cerebral Concussion, Concussion, Intermediate, Concussion, Mild, Concussion, Severe, Trauma, Nervous System, Craniocerebral Trauma, Brain Injuries

In brief

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic.

Key facts

Study ID

NCT02776462

Run by

Oculogica, Inc.

People needed

321

Starts

2016-06-01

Expected to finish

2018-06-19

Last updated by the study team

2018-09-07

Who can join

Age: 5 and older, up to 67. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent.
• Be between the ages of 4 and 67 years old.
• Have a diagnosis of traumatic brain injury with a potential for concussion.
• Subjects must have baseline vision correctable to within 20/500 bilaterally.
• Subjects must have intact ocular motility.
• Subjects must have ability to provide a complete ophthalmologic, medical and neurologic history as well as medications/drugs/alcohol consumed within the 24 hours prior.

You may not qualify if…

• ER visit has been more than 2 weeks since the injury which may have caused the concussion.
• Have received penetrating trauma or have a head CT demonstrating evidence of acute brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
• Suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability.
• Blind (no light perception), are missing eyes, do not open eyes.
• It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant.
• Previous history of: ocular motility dysfunction or extensive prior eye surgery.
• Any physical or mental injury or baseline disability rendering task completion difficult.
• Obvious intoxication or blood alcohol level greater than 0.2.

Where it is running

• SkyRidge Medical Center — Lone Tree, Colorado, United States
• Beaver Dam Community Hospital — Beaver Dam, Wisconsin, United States

Full record on ClinicalTrials.gov

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