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

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year–26 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Michigan NeuroSport Concussion Program

Ann Arbor, Michigan, 48105, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Change of Brain Network Activation(BNA™)Scores

Time frame: 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 outcomes

Correlation Of The Change In BNA™ Scores To Clinical Diagnstic

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

ElMindA Ltd

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Feb 17, 2012
Registry last updated: Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed