Clinical trial NCT02776462: Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
Official title: Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Concussion
Cerebral Concussion
Concussion, Intermediate
Concussion, Mild
Concussion, Severe
Trauma, Nervous System
Craniocerebral Trauma
Brain Injuries
Keywords: Eye Tracking
Concussion
Outcome Measures
Lead sponsor: Oculogica, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-18
Enrollment: 321
Sex: ALL
Minimum age (years): 5
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: A change in metrics of eye movement that enable positive concussion detection using BOX Score.
timeFrame: Immediately after eye tracking, within 2 weeks of injury
Secondary outcomes:
measure: Change in Cognitive Function and Symptom Severity during Recovery as Measured with a Clinical Reference Standard for Concussion.
timeFrame: Immediately before eye tracking, between 1 week and 109 weeks post injury
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: SkyRidge Medical Center
state: Colorado
city: Beaver Dam
country: United States
facility: Beaver Dam Community Hospital
state: Wisconsin
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Uzma Samadani, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.