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

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ClinicalTrials.gov Identifier: NCT02776462
Recruitment Status : Completed
First Posted : May 18, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Oculogica, Inc.

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.

Condition or disease Intervention/treatment
Brain Concussion Cerebral Concussion Concussion, Intermediate Concussion, Mild Concussion, Severe Trauma, Nervous System Craniocerebral Trauma Brain Injuries Device: EyeBox CNS

Study Type : Observational
Actual Enrollment : 321 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
Study Start Date : June 2016
Actual Primary Completion Date : November 16, 2017
Actual Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine


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



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


Secondary Outcome Measures :
  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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Ages Eligible for Study:   5 Years to 67 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776462


Locations
United States, Colorado
SkyRidge Medical Center
Lone Tree, Colorado, United States, 80124
United States, Wisconsin
Beaver Dam Community Hospital
Beaver Dam, Wisconsin, United States, 53916
Sponsors and Collaborators
Oculogica, Inc.
Investigators
Study Chair: Uzma Samadani, M.D., Ph.D. Hennepin County Medical Center, Minneapolis

Publications:
Responsible Party: Oculogica, Inc.
ClinicalTrials.gov Identifier: NCT02776462     History of Changes
Other Study ID Numbers: DETECT TBI001
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Oculogica, Inc.:
Eye Tracking
Concussion
Outcome Measures

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Craniocerebral Trauma
Trauma, Nervous System
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Head Injuries, Closed
Wounds, Nonpenetrating