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

NCT01535339 | Completed

• 1 other identifier: ELM-03
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury

Keywords

mild Traumatic Brain Injury; mTBI; Concussion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

Phase I - Normative

Athletes who does not participate in contact sport with no recent concussion

Phase IIa - Concussed

Athletes with recent concussion

Phase IIa - Control

Athletes with no recent concussion

Phase IIb - Athletes

Athletes with no recent concussion

Eligibility Criteria

• Age: 14 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Phase 1: gender-balanced groups of 30 healthy high school (14-17 years old) and 30 healthy college aged (18-26 years old) individuals who participate in non-contact sports Phase 2a: 30 high school and/or collegiate athletes aged 14-26 years with concussion and 30 matched control athletes. Phase 2b: at least 30 high school and/or collegiate contact sport athletes aged 14-26 years whose head impacts are monitored during games and practices.

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (1)

Michigan NeuroSport Concussion Program

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2012
• First Posted: February 17, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)