Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
NCT ID: NCT02776462
Last Updated: 2018-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
321 participants
OBSERVATIONAL
2016-06-30
2018-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Potential Traumatic Brain Injury
This group will consist of people admitted to the ER, Trauma Bay, or Neurosurgery for potential traumatic brain injury.
EyeBox CNS
Interventions
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EyeBox CNS
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
67 Years
ALL
No
Sponsors
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Oculogica, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Uzma Samadani, M.D., Ph.D.
Role: STUDY_CHAIR
Hennepin County Medical Center, Minneapolis
Locations
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SkyRidge Medical Center
Lone Tree, Colorado, United States
Beaver Dam Community Hospital
Beaver Dam, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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DETECT TBI001
Identifier Type: -
Identifier Source: org_study_id
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