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

Completed

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT01535339
• Lead Sponsor: ElMindA Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-12
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Michigan NeuroSport Concussion Program; 🇺🇸 Ann Arbor, Michigan, United States