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CompletedNCT01535339Updated Sep 25, 2019

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

An observational study in Mild Traumatic Brain Injury, sponsored by ElMindA Ltd. Completed at 1 site in United States. Open to participants aged 14 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by ElMindA Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
109
Ages
14 Years to 26 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mild Traumatic Brain Injury

Keywords

  • mild Traumatic Brain Injury
  • mTBI
  • Concussion
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 109 is close to the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

ElMindA Ltd is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
109 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • Michigan NeuroSport Concussion Program
    Ann Arbor, Michigan 48105, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01535339
Lead sponsor
ElMindA Ltd
Responsible party
Sponsor
First posted
Feb 17, 2012
Start date
Feb 2012
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Sep 25, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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