Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Robert Spinner, M.D. |
Closed for enrollment |
|
More information
Publications
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Disconjugate eye movements have been associated with traumatic brain injury since ancient times. Ocular motility dysfunction may be present in up to 90% of patients with concussion or blast injury. We developed an algorithm for eye tracking in which the Cartesian coordinates of the right and left pupils are tracked over 200 sec and compared to each other as a subject watches a short film clip moving inside an aperture on a computer screen. We prospectively eye tracked 64 normal healthy noninjured control subjects and compared findings to 75 trauma subjects with either a positive head computed tomography (CT) scan (n=13), negative head CT (n=39), or nonhead injury (n=23) to determine whether eye tracking would reveal the disconjugate gaze associated with both structural brain injury and concussion. Tracking metrics were then correlated to the clinical concussion measure Sport Concussion Assessment Tool 3 (SCAT3) in trauma patients. Five out of five measures of horizontal disconjugacy were increased in positive and negative head CT patients relative to noninjured control subjects. Only one of five vertical disconjugacy measures was significantly increased in brain-injured patients relative to controls. Linear regression analysis of all 75 trauma patients demonstrated that three metrics for horizontal disconjugacy negatively correlated with SCAT3 symptom severity score and positively correlated with total Standardized Assessment of Concussion score. Abnormal eye-tracking metrics improved over time toward baseline in brain-injured subjects observed in follow-up. Eye tracking may help quantify the severity of ocular motility disruption associated with concussion and structural brain injury.
Read More on PubMed
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Automated eye movement tracking may provide clues to nervous system function at many levels. Spatial calibration of the eye tracking device requires the subject to have relatively intact ocular motility that implies function of cranial nerves (CNs) III (oculomotor), IV (trochlear), and VI (abducent) and their associated nuclei, along with the multiple regions of the brain imparting cognition and volition. The authors have developed a technique for eye tracking that uses temporal rather than spatial calibration, enabling detection of impaired ability to move the pupil relative to normal (neurologically healthy) control volunteers. This work was performed to demonstrate that this technique may detect CN palsies related to brain compression and to provide insight into how the technique may be of value for evaluating neuropathological conditions associated with CN palsy, such as hydrocephalus or acute mass effect.
Read More on PubMed