Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion

Study Overview
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Brief Summary
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Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. This makes the clinical diagnosis of concussion particularly difficult as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Given the variability in concussion presentations, there is no single test that can diagnose a concussion. Current recommendations are that sports medicine providers apply a multifaceted concussion assessment battery that combines subjective symptoms, motor control and cognitive assessment. This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries. This study will establish the reliability of BNA™ scores over clinically relevant assessment intervals and investigate the effect of SRC and sub-concussive head impacts on BNA scores.

Official Title
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Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion

Conditions
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Mild Traumatic Brain Injury

Participation Criteria
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Eligibility Criteria
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Phase 1: Inclusion Criteria: Aged 14-26 years Enrolled in a recognized high school or college Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self) Currently participate in a non-contact sport. Member of an organized athletic team or regularly train for and participate in independent athletic contests during at least one sports season. Right handed subject Exclusion Criteria: Currently participate in a contact sport. Bald or has dread locks/long and thick hair. Any diagnosed psychiatric disorder History of CNS injury or disease Any neuropsychological disorders History of learning disability. History of any medication affecting CNS. Active head lice infection, open scalp wound, deafness or/and blindness. Sustained a diagnosed concussion within the previous 6 months Phase 2a: Inclusion Criteria: Aged 14-26 years. For Arm 1: Within 1 week post-concussion (sports-related). For Arm 1: 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). Member of an organized athletic team or regularly train. Enrolled in a high school or college. Exclusion Criteria: Bald or has dread locks/long and thick hair. Current or history of ADHD. Active head lice infection, open scalp wound, deafness or/and blindness. Sustained a concussion within the past 6 months. Current or history of moderate or severe TBI, any brain injury with positive neuroimaging findings, or brain surgery. Phase 2b: Inclusion Criteria: Aged 14-26 years. Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self). Member of a contact sport team which carries out head impact monitoring over the course of the playing season. Enrolled in a high school or college. Exclusion Criteria: Bald or has dread locks/long and thick hair. Current or history of ADHD. Active head lice infection, open scalp wound, deafness or/and blindness. Sustained a concussion within the past 6 months. Current or history of moderate or severe TBI, any brain injury with positive neuroimaging findings, or brain surgery. Any diagnosed psychiatric disorder. History of CNS injury or disease Any neuropsychological disorders. History of learning disability. History of any medication affecting CNS.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 26 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 |
| --- | --- |
| Phase I - Normative<br>Athletes who does not participate in contact sport with no recent concussion | |
| Phase IIa - Concussed<br>Athletes with recent concussion | |
| Phase IIa - Control<br>Athletes with no recent concussion | |
| Phase IIb - Athletes<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 |  | P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Of The Change In BNA™ Scores To Clinical Diagnstic |  | P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season | 
| Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scroes |  | P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season | 
| Correlation Of The Change In BNA™ Scores To Reaction Time Scores |  | P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season | 

 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