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

Completed

• Conditions: Cerebral Concussion; Concussion, Mild; Concussion, Severe; Brain Concussion; Concussion, Intermediate; Trauma, Nervous System; Craniocerebral Trauma; Brain Injuries
• Interventions: Device: EyeBox CNS

• Registration Number: NCT02776462
• Lead Sponsor: Oculogica, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Study Start: 2016-06
• Primary Completion: 2017-11-16
• Study Completion: 2018-06-19
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Potential Traumatic Brain Injury	EyeBox CNS	This group will consist of people admitted to the ER, Trauma Bay, or Neurosurgery for potential traumatic brain injury.

Primary Outcome Measures

Name	Time	Method
A change in metrics of eye movement that enable positive concussion detection using BOX Score.	Immediately after eye tracking, within 2 weeks of injury	A True Positive rate for identifying Concussion as compared to a Clinical Reference standard.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

SkyRidge Medical Center; 🇺🇸 Lone Tree, Colorado, United States

Beaver Dam Community Hospital; 🇺🇸 Beaver Dam, Wisconsin, United States