A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion

Study Overview
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Brief Summary
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The main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes. In addition, the study will examine the relationship between changes in BNA to symptoms, cognitive performance and vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high school athletes with concussion.

Official Title
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A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion

Conditions
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Mild Traumatic Brain Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 13-18 years 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/or consent (parent for minors or adult 18+ years of age for self) Exclusion Criteria: Current or history of TBI (i.e., Glasgow Coma Scale <13) or brain surgery Current or history of any psychiatric disorder (except ADD/ADHD), e.g., depression, bipolar disorder, schizophrenic disorder Substance abuse within the last year Current or history of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder Current or history of any Neurological disorder, e.g., epilepsy, seizures History of any medication affecting CNS within the last year, e.g., antidepressants, anticonvulsants, Ritalin, first generation antihistamines, etc. Current or history of Significant sensory deficits such as deafness or blindness Current or history of Clinically significant abnormal laboratory values or ECG A concussion within the last year Current or history of residual symptoms or deficits related to a previous concussion Diagnosis of autistic spectrum disorders, e.g., Asperger's syndrome, High functioning Autism, PDD Currently with lice or open wounds on scalp Long and thick hair that prevents the proper administration of an EEG cap

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High School Athletes<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period | To examine prospectively changes in brain network activation (BNA) from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion. | baseline, 1-7, 8-14, and 15-21 day post-injury intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period | To investigate the relationship between changes in BNA to changes in symptoms from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion. | baseline, 1-7, 8-14, and 15-21 day post-injury intervals | 
| Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period | To investigate the relationship between changes in BNA to changes in cognitive performance from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion. | baseline, 1-7, 8-14, and 15-21 day post-injury intervals | 
| Relationship between changes in BNA to changes in vestibular function from baseline over post concussion recovery period | To investigate the relationship between changes in BNA to changes in vestibular function from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion. | baseline, 1-7, 8-14, and 15-21 day post-injury intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mTBI, Concussion, mild Traumatic Brain Injury