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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date May 16, 2016
First Posted Date May 18, 2016
Last Update Posted Date September 7, 2018
Study Start Date June 2016
Actual Primary Completion Date November 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2018)
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.
Original Primary Outcome Measures
 (submitted: May 17, 2016)
A change in metrics of eye movement that enable positive concussion detection using BOX Score. [ Time Frame: Immediately after eye tracking, within 24 hours of admission. ]
A True Positive rate for identifying Concussion as compared to a Clinical Reference standard.
Change History
Current Secondary Outcome Measures
 (submitted: September 5, 2018)
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 ]
Original Secondary Outcome Measures
 (submitted: May 17, 2016)
Change in Cognitive Function and Symptom Severity during Recovery as Measured with a Clinical Reference Standard for Concussion. [ Time Frame: Immediately before eye tracking, within 24 hours of admission. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Brain Concussion
  • Cerebral Concussion
  • Concussion, Intermediate
  • Concussion, Mild
  • Concussion, Severe
  • Trauma, Nervous System
  • Craniocerebral Trauma
  • Brain Injuries
Intervention Device: EyeBox CNS
Study Groups/Cohorts Potential Traumatic Brain Injury
This group will consist of people admitted to the ER, Trauma Bay, or Neurosurgery for potential traumatic brain injury.
Intervention: Device: EyeBox CNS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 5, 2018)
321
Original Estimated Enrollment
 (submitted: May 17, 2016)
400
Actual Study Completion Date June 19, 2018
Actual Primary Completion Date November 16, 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 67 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02776462
Other Study ID Numbers DETECT TBI001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Oculogica, Inc.
Study Sponsor Oculogica, Inc.
Collaborators Not Provided
Investigators
Study Chair: Uzma Samadani, M.D., Ph.D. Hennepin County Medical Center, Minneapolis
PRS Account Oculogica, Inc.
Verification Date September 2018