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

Sponsor

Oculogica, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02776462

Collaborator

(none)

321

Enrollment

Locations

24.6

Duration (Months)

160.5

Patients Per Site

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Concussion Cerebral Concussion Concussion, Intermediate Concussion, Mild Concussion, Severe Trauma, Nervous System Craniocerebral Trauma Brain Injuries	Device: EyeBox CNS

Study Design

Study Type:

Observational

Actual Enrollment :

321 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Nov 16, 2017

Actual Study Completion Date :

Jun 19, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Potential Traumatic Brain Injury

This group will consist of people admitted to the ER, Trauma Bay, or Neurosurgery for potential traumatic brain injury.

Device: EyeBox CNS

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.