Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults

Study Overview
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Brief Summary
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The use of Event Related Potentials (ERP) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred. However, little is known about the immediate changes in brain activity in specific brain regions and connectivity across them associated with performance on specific neurocognitive tests following a concussion, and the subsequent changes over time. The proposed study will provide initial evidence for the feasibility of an ERP based biomarker for concussion reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion.

Official Title
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Comparison of Brain Network Activation Analysis (BNA™) Using Evoked Response Potentials, Clinical Symptoms and Neuro-cognitive Performance and Symptoms in Concussed Children, Young Adults and Matched Controls

Conditions
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Traumatic Brain Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 14-27 years Arm 1 only (Concussed): Over 2 days and below 10 days post-concussion (sports-related) Currently symptomatic 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: TBI (i.e., Glasgow Coma Scale <13) or brain surgery Any psychiatric disorder Substance abuse Special education Any Neurological disorder Any medication affecting CNS Significant sensory deficits such as deafness or blindness Clinically significant abnormal laboratory values or ECG A history of more than 3 concussions in the past A concussion within the last year Residual symptoms or deficits related to a previous concussion

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 27 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 |
| --- | --- |
| Concussed<br>Patients with recent concussion | |
| Matched controls<br>Athletes with no recent concussion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Brain Network Activation(BNA™)Scores Over Post Concussion Recovery Period |  | days 2-10, 7-19, 12-28, 17-37 following concussion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scores and Clinical Diagnostic |  | days 2-10, 7-19, 12-28, 17-37 following concussion | 

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