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

NCT02776462 | Completed FDA Device

• 1 other identifier: DETECT TBI001
• Study Type: observational
• Target: 321
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Eye Tracking; Concussion; Outcome Measures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

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

Interventions

EyeBox CNS DEVICE

Potential Traumatic Brain Injury

Eligibility Criteria

• Age: 5 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oculogica, Inc.: lead

Study Sites (2)

SkyRidge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Beaver Dam Community Hospital

Beaver Dam, Wisconsin, 53916, United States

Location

Related Publications (3)

• 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.

  PMID: 26487847 BACKGROUND

• 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.

  PMID: 25582436 BACKGROUND

• 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.

  PMID: 25495739 BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Trauma, Nervous System; Craniocerebral Trauma; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Uzma Samadani, M.D., Ph.D.

  Hennepin County Medical Center, Minneapolis

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 18, 2016
• Study Start: June 1, 2016
• Primary Completion: November 16, 2017
• Study Completion: June 19, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)