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

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion; Concussion, Mild; Concussion, Severe; Concussion, Intermediate; Cerebral Concussion
• Intervention / Treatment: Device: EyeBox CNS

• Study Type: Observational
• Enrollment (Actual): 321

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Skyridge Medical Center
  • Wisconsin
    • Beaver Dam, Wisconsin, United States, 53916
      • Beaver Dam Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 67 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants will include all patients evaluated for potential traumatic brain injury presenting to the Emergency Department or concussion clinic.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Oculogica, Inc.
• Investigators: Study Chair: Uzma Samadani, M.D., Ph.D., Hennepin County Medical Center, Minneapolis

Publications and helpful links

General Publications

• Samadani U. A new tool for monitoring brain function: eye tracking goes beyond assessing attention to measuring central nervous system physiology. Neural Regen Res. 2015 Aug;10(8):1231-3. doi: 10.4103/1673-5374.162752. No abstract available.
• Samadani U, Ritlop R, Reyes M, Nehrbass E, Li M, Lamm E, Schneider J, Shimunov D, Sava M, Kolecki R, Burris P, Altomare L, Mehmood T, Smith T, Huang JH, McStay C, Todd SR, Qian M, Kondziolka D, Wall S, Huang P. Eye tracking detects disconjugate eye movements associated with structural traumatic brain injury and concussion. J Neurotrauma. 2015 Apr 15;32(8):548-56. doi: 10.1089/neu.2014.3687. Epub 2015 Feb 6.
• Samadani U, Farooq S, Ritlop R, Warren F, Reyes M, Lamm E, Alex A, Nehrbass E, Kolecki R, Jureller M, Schneider J, Chen A, Shi C, Mendhiratta N, Huang JH, Qian M, Kwak R, Mikheev A, Rusinek H, George A, Fergus R, Kondziolka D, Huang PP, Smith RT. Detection of third and sixth cranial nerve palsies with a novel method for eye tracking while watching a short film clip. J Neurosurg. 2015 Mar;122(3):707-20. doi: 10.3171/2014.10.JNS14762. Epub 2014 Dec 12.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 16, 2017
• Study Completion (Actual): June 19, 2018

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Concussion; Outcome Measures; Eye Tracking
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion
• Other Study ID Numbers: DETECT TBI001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No