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

• ClinicalTrials.gov Identifier: NCT02776462
• Recruitment Status: Completed
• First Posted: May 18, 2016
• Last Update Posted: September 7, 2018
• Sponsor: Oculogica, Inc.
• 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.

• 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 *

• 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.
• 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.

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

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