Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 14 - 26 |
| Updated: | 4/21/2016 |
| Start Date: | February 2012 |
| End Date: | December 2015 |
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.
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.
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.
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