An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
Condition: Healthy; Minor Traumatic Brain Injury (TBI)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing
      changes in brain activity associated with concussion. Event Related Potentials (ERPs), which
      are temporal reflections of the neural mass electrical activity of cells in specific regions
      of the brain that occur in response to stimuli, may offer such a method, as they provide both
      a noninvasive and portable measure of brain function. The ERPs provide excellent temporal
      information, but spatial resolution for ERPs has traditionally been limited. However, by
      using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is
      improved significantly. The paradigm for the current study will combine neurophysiological
      knowledge with mathematical signal processing and pattern recognition methods (BNA™) to
      temporally and spatially map brain function, connectivity and synchronization.

      The proposed study will provide additional evidence for the utility and contribution of the
      BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain
      functional connectivity associated with concussion) in concussion management.

      The BNA test is basically divided to 3 phases - first EEG data is collected from subjects
      using an EEG system while the subject is performing a cognitive task in front of a computer.
      The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the
      BNA™ test is generated.
    

Detailed description: 
      A single center study evaluating the effectiveness of BNA technology as an objective tool for
      sport related concussion management in youth athletes' populations.

      The study will include 150 athletes from Minnesota Youth Hockey Programs. Subjects enrolled
      in this study will undergo a screening and baseline pre season visit and follow up visit/s.

        1. Follow-up testing for concussed athletes - Concussed athletes will complete a series of
           post concussion follow up visits. Each will consist of BNA™ test, ImPACT™ test, and exam
           by neurologist or neurology nurse practitioner. The first visit will be within 72 hours
           of injury and re-evaluations will occur weekly until BNA has normalized AND subject is
           asymptomatic. Subject may return to play at that point and subject will have a final
           additional BNA™ test one week after the athlete returns to full activity. If participant
           is still symptomatic and/or BNA is still abnormal at 6 weeks reevaluations go to every 2
           weeks for up to three months or clearing of symptoms AND normal BNA™. If not back to
           baseline at three months, monthly reevaluations until study completion.

        2. Follow up visit for non-concussed athletes - non-concussed athletes will complete a
           follow up visit upon completion of the sport season.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        150 male athletes enrolled in Minnesota Youth Hockey Programs, aged 11-15 years.