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

Oculogica, Inc.2 sites in 1 country321 target enrollmentJune 2016

ConditionsBrain Concussion Cerebral Concussion Concussion, Intermediate Concussion, Mild Concussion, Severe Trauma, Nervous System Craniocerebral Trauma Brain Injuries

Overview

Phase: N/A
Intervention: Not specified
Conditions: Brain Concussion
Sponsor: Oculogica, Inc.
Enrollment: 321
Locations: 2
Primary Endpoint: A change in metrics of eye movement that enable positive concussion detection using BOX Score.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

June 19, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Oculogica, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

A change in metrics of eye movement that enable positive concussion detection using BOX Score.

Time Frame: Immediately after eye tracking, within 2 weeks of injury

A True Positive rate for identifying Concussion as compared to a Clinical Reference standard.

Secondary Outcomes

Change in Cognitive Function and Symptom Severity during Recovery as Measured with a Clinical Reference Standard for Concussion.(Immediately before eye tracking, between 1 week and 109 weeks post injury)