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

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-006102
    NCT ID: NCT02776462
    Sponsor Protocol Number: 16-006102

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Subjects will need to consent in compliance with 21 Code of Federal Regulations (CFR) Part 56 and able/willing to participate and meet criteria 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.
  • Inability to participate in longitudinal care.
  • Obvious intoxication or blood alcohol level greater than 0.2.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Spinner, M.D.

Contact us for the latest status

Contact information:

Bambi Wessel

(507)293-1963

Wessel.Bambi@mayo.edu

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CLS-20272706

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