Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Condition: Mild Traumatic Brain Injury; Brain Concussion; Convergence Insufficiency; Accommodative Insufficiency; Saccadic Eye Movement Deficiency; Oculomotor Dysfunction
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Ocular Motility Disorders; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this single center, longitudinal, pilot study is to provide evidence for the
      use of an eye tracking system as an objective tool to identify mild traumatic brain injury
      (mTBI) related oculomotor dysfunction (OMD) and predict the effectiveness of neurovision
      rehabilitation (NVR) of OMD. Eye tracking visual stimulus measurements will be compared to
      objective developmental optometrist (OD) diagnosis and assessments. It will be determined
      whether an eye tracking system can predict the presence or absence of mTBI related OMD and
      whether mTBI patients who have OMD based on the eye tracking system will respond positively
      to NVR.
    

Detailed description: 
      The primary objectives are: 1) To demonstrate that measurements from visual stimulus and eye
      tracking system will predict the presence or absence of traumatic brain injury related vision
      disorder, i.e. oculomotor dysfunction (OMD) as diagnosed by a developmental optometrist (OD).
      2) To use the eye tracking visual measurements to predict the effectiveness of neurovision
      rehabilitation (NVR) on post-traumatic OMD by comparing the data obtained to the objective
      visual measurements found on the OD examination.

      Mild traumatic brain injury (mTBI) that alters brain function is a major public health
      concern of significant personal and societal burden. Mild traumatic brain injury patients may
      experience any or all of at least 20 symptoms, with some persisting for weeks to months and
      increasing the risk of comorbidities. Current mTBI diagnosis and treatment are subjective and
      imprecise rather than objective and patient specific. Despite the varied heterogeneous
      manifestations of mTBI based on location and severity of injury as well as predisposing
      factors, treatment is generic and lacking in active therapies: rest with the avoidance of
      devices/screens to avoid exacerbating symptoms. This "one size fits all" approach is
      suboptimal, often resulting in ineffective management with prolonged inadequate recovery.
      Recent evidence suggests effective therapies to be specific to the mTBI patient and their
      symptoms with promising interventions targeting vestibular deficits as well as post-TBI OMD
      NVR. Neurovision rehabilitation is analogous to physical therapy for the eyes and improves
      the connection between the brain and the eyes with prior research finding NVR to be very
      effective for patients with post-concussion visual dysfunctions. Patients with potential mTBI
      primarily present to the emergency department, primary care, or specialty clinic, where there
      lacks proper equipment, training, and time for a comprehensive vision examination.
      Additionally, identification and diagnosis of OMD is only conducted currently by a vision
      specialist or highly skilled TBI specialists. This leaves a majority of OMD patients with
      inappropriate diagnosis and inadequate work or school accommodations as well as without
      treatment with NVR, lenses, and prisms. Thus an objective, easily accessible tool to identify
      mTBI related OMD would greatly advance clinical care.

      This trial is a single center, longitudinal, pilot study. One hundred mTBI patients with OMD,
      confirmed with objective testing by a OD, who fit inclusion/exclusion criteria will be
      initially identified by providers at the Hennepin County Medical Center (HCMC) TBI Clinic. No
      subject will be excluded on the basis of sex/gender, race or ethnicity. If interested,
      subjects will be consented then undergo an initial eye tracking. Within two weeks of the
      initial eye tracking, subjects will begin recommended NVR with occupational therapists (OT)
      at HCMC. Each NVR session will assess each subject's progress and following each NVR session,
      subjects will receive an eye tracking test. Additionally, within two months of the initial
      OMD diagnosis patients will follow up with the OD every two months until their OMD is
      resolved or until one year following their diagnosis. Subjects will also undergo an eye
      tracking test after each OD follow up appointment. Eye tracking visual stimulus measurements
      will be compared to OD diagnostic measurements and assessments.

      The goals of this research study are to improve objective, timely identification of mTBI
      related visual dysfunctions and assessment of the effectiveness of NVR. A positive outcome
      will greatly impact diagnosis and care of mTBI patients with vision dysfunction, as objective
      assessments will be more widely and readily available and NVR will be more utilized by the
      medical community. Overall post-mTBI functional outcomes will improve, significantly
      lessening this major public health concern affecting patients, families, communities, and
      society.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Mild traumatic brain injury patients who meet the inclusion/exclusion criteria.