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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535339
• Other study ID #: ELM-03
• Status: Completed
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: September 2019
• Source: ElMindA Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Michigan NeuroSport Concussion Program	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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