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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by ElMindA Ltd
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd
ClinicalTrials.gov Identifier:
NCT01535339
First received: February 12, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition
Mild Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion

Resource links provided by NLM:


Further study details as provided by ElMindA Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Ages Eligible for Study:   14 Years to 26 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535339

Contacts
Contact: Courtney McDonald 734.255.9095 clkenned@med.umich.edu

Locations
United States, Michigan
Michigan NeuroSport Concussion Program Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Courtney McDonald    734-255-9095    clkenned@med.umich.edu   
Principal Investigator: Jeffrey S Kutcher, MD         
Sub-Investigator: James T Eckner, MD         
Sub-Investigator: Steve Broglio, Phd         
Sponsors and Collaborators
ElMindA Ltd
  More Information

No publications provided

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT01535339     History of Changes
Other Study ID Numbers: ELM-03
Study First Received: February 12, 2012
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by ElMindA Ltd:
mild Traumatic Brain Injury
mTBI
Concussion

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014