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CompletedNCT02776462DETECTUpdated Sep 7, 2018

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

An observational study in Brain Concussion, Cerebral Concussion and Concussion, Intermediate, sponsored by Oculogica, Inc.. Completed at 2 sites in United States. Open to participants aged 5 Years to 67 Years. Per ClinicalTrials.gov, last updated 2018-09-07.

Sponsored by Oculogica, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
321
Ages
5 Years to 67 Years
Sex
All
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Study 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.

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Conditions studied

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

Keywords

  • Eye Tracking
  • Concussion
  • Outcome Measures
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 321 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Oculogica, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 67 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
321 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceEyeBox CNS
06

What researchers measure

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.

    Time frame: 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.

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

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Study locations

2 sites
  • SkyRidge Medical Center
    Lone Tree, Colorado 80124, United States
  • Beaver Dam Community Hospital
    Beaver Dam, Wisconsin 53916, United States
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References and documents

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. PubMed 26487847 ↗
  • 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. PubMed 25582436 ↗
  • 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. PubMed 25495739 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02776462
Lead sponsor
Oculogica, Inc.
Responsible party
Sponsor
First posted
May 18, 2016
Start date
Jun 2016
Primary completion
Nov 16, 2017
Completion
Jun 19, 2018
Last update
Sep 7, 2018

Study contacts

Uzma Samadani, M.D., Ph.D.
study chair · Hennepin County Medical Center, Minneapolis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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