Neuroimaging and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Condition: Traumatic Brain Injury; Vision Difficulty
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational

Summary: 
      Mild TBI subjects will initially be identified by providers in the Hennepin County Medical
      Center (HCMC) TBI Clinic. The subjects will then undergo objective testing by the
      developmental optometrist to confirm if they do or do not have vision dysfunction related to
      the mTBI. At the Center of Magnetic Resonance Research (CMRR) located at the University of
      Minnesota (U of M), the whole brain will be imaged using resting state and task functional
      MRI and diffuse tensor imaging (DTI) using a high field 3 Tesla (T) MRI. The subjects will
      then receive neurovision rehabilitation if they are in the vision dysfunction group. This
      treatment is standard care. Both groups will then undergo repeat objective vision testing by
      the developmental optometrist at 3 and 6 months to confirm that vision dysfunction has
      resolved. Resting state and task fMRI and DTI will be done at the same time to compare
      functional and structural connectivity changes between the 2 groups.
    

Detailed description: 
      The primary objectives are: 1) To localize changes following mild traumatic brain injury
      (mTBI) in subjects with vision dysfunction using functional magnetic resonance imaging (fMRI)
      and diffusion tensor imaging (DTI). 2) To demonstrate the effectiveness of neuro vision
      rehabilitation (NVR) on vision dysfunction initiated within nine months following mTBI by
      normalizing objective visual measurements as well as changes on fMRI and DTI.

      Mild (TBI) comprises 80% of the 3.65 million brain injuries in the United States and costs an
      estimated 17 billion dollars annually. Mild TBI is a challenging diagnosis and can be as
      disabling as a severe TBI when chronic symptoms develop. In the past several years,
      researchers have found that a somewhat silent majority of mTBI patients who develop lasting
      symptoms have concurrent vision dysfunction. This cohort of patients with post-traumatic
      visual difficulty, regardless of mechanism of injury, seem to demonstrate more significant
      and lasting disability and poorer overall outcome than other TBI cohorts, yet these
      correlations have not been adequately studied. The studies that have been performed have
      found that visual dysfunctions may not spontaneously improve and become chronic in absence of
      direct diagnosis and treatment. Time after injury has been shown in studies to have no
      influence on incidence or frequency of visual difficulties but once identified, these
      pervasive visual dysfunctions significantly improve in response to interventions such as
      prescription glasses and NVR.

      For the past 16 months, the Center for Magnetic Resonance Research (CMRR) at the University
      of Minnesota (U of M) and the TBI Center at the Hennepin County Medical Center (HCMC) have
      closely collaborated in a pilot study. The goal of this study was to identify the location in
      the brain of post traumatic visual changes in acute mTBI subjects (< 9 months from injury
      date, ages 18-55) using resting state and task fMRI and DTI. Mild TBI subjects who had vision
      dysfunction (vision group) were compared to mTBI subjects who did not have any vision
      difficulties (controls). Task fMRI imaging demonstrated significant decreased brain activity
      in the vision dysfunction subjects as compared to the controls in certain key vision areas.
      Diffusion tensor imaging showed significant changes in certain areas of the corpus callosum.

      This trial is designed as a longitudinal clinical study. Fifteen mTBI patients with vision
      dysfunction (vision group) fitting the inclusion/exclusion criteria and 15 patients with mTBI
      but with no findings on the visual screen (control group) within 9 months of their injury
      will be included in the study. No subject will be excluded on the basis of sex/gender, race
      or ethnicity. These mTBI subjects will initially be identified by physicians in the HCMC TBI
      Clinic. If agreeable, consent will be obtained at both HCMC as well as prior to their
      baseline MRI scans at CMRR. The subjects will then undergo objective testing by a specialized
      eye doctor at HCMC to confirm if they do or do not have vision dysfunction related to the
      mTBI. At CMRR, within 2 weeks of the visual testing, the whole brain will be imaged using
      resting state and task fMRI and DTI using a 3T MRI machine. The subjects will then receive
      neurovision rehabilitation for approximately 3 months at HCMC if they are in the vision
      group. This treatment is standard care for this population. Both groups will then undergo
      repeat objective vision testing by the specialized eye doctor at 3 and 6 months to confirm
      that vision dysfunction has resolved. Resting state and task fMRI and DTI will be done at the
      same time to compare functional and structural connectivity changes between the 2 groups.

      Mild TBI is a significant cause of disability especially when symptoms become chronic. In
      HCMC's clinical experience, this chronicity is often linked to vision difficulties. Vision
      dysfunction will continue until properly identified and treated, especially with neuro vision
      rehabilitation. The goals of this research study are to better understand cerebral structural
      and metabolic changes associated with as well as the effectiveness of neuro vision
      rehabilitation on post traumatic vision dysfunction by utilizing resting state and task fMRI
      and DTI. A positive outcome will have a significant impact on the diagnosis and care of the
      considerable numbers of mTBI patients suffering from vision dysfunction, especially because
      neurovision rehabilitation will be more utilized by the medical community. In turn, the
      overall functional outcomes after mTBI will improve, greatly relieving the suffering and
      disability for these patients.
    

Intervention name(s): neuro vision rehabilitation
Intervention type(s): Other
Intervention description(s): Neuro vision rehabilitation used to treat vision dysfunction following TBI
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have suffered a mild traumatic brain injury who fit the below
        inclusion/exclusion criteria.