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

Oculogica

Status: Completed

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

Treatments: Device: EyeBox CNS

Study type: Observational

Funder types: Industry

Identifiers

NCT02776462

DETECT TBI001

Details and patient eligibility

About

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.

Enrollment: 321 patients

Sex: All

Ages: 5 to 67 years old

Volunteers: No 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.

Trial design

321 participants in 1 patient group

Potential Traumatic Brain Injury

Description:

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

Treatment:

Device: EyeBox CNS