Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes

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.

Inclusion Criteria:

- • Male and Female Athletes: Age 8-14 (Arm 1) or 8-18 years (Arm 2).

- For Arm 1 - Over 3 days and below 7 days post-concussion (sports-related) and
currently symptomatic

- Able to speak, read and understand English sufficiently to understand the nature
of the study, and to allow completion of all study assessments.

- Willingness to participate and able to give informed assent (child) and Parental
consent

Exclusion Criteria:

- Currently with lice or open wounds on scalp.

- Long and thick hair that prevents the proper administration of an EEG cap.

- Significant sensory deficits, e.g., deafness or blindness.

- Normative Exclusion Criteria:

- Any chronic disease as determined by clinical evaluation and medical history.

- Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder,
etc. as determined by clinical evaluation and the Mini International Neuropsychiatric
Interview (MINI)

- Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical
evaluation

- Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc.
as determined by clinical evaluation

- History of Special education, e.g., reading disorder (dyslexia), writing disorder
(dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.

- History of any medication affecting CNS within the last 3 months, e.g.,
antidepressants, anticonvulsants, psychostimulants, first generation antihistamines,
etc.

- Substance abuse in the last 3 months.

- History of any clinically significant brain trauma as determined by the investigator.