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OpenTrials
Completed

NCT Number: NCT02776462

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

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.

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Key information

Conditions

Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cerebral Concussion Concussion, Intermediate Concussion, Mild Concussion, Severe Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

5 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SkyRidge Medical Center, Lone Tree, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EyeBox CNS

Device

Primary outcomes

  1. 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

  1. Change in Cognitive Function and Symptom Severity during Recovery as Measured with a Clinical Reference Standard for Concussion.

    Time frame: Immediately before eye tracking, between 1 week and 109 weeks post injury

Sponsors and collaborators

Lead sponsor

Oculogica, Inc.

Industry

Registry information

Acronym: DETECT

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 18, 2016
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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