A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by ElMindA Ltd
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd
ClinicalTrials.gov Identifier:
NCT01673464
First received: August 21, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

The main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes. In addition, the study will examine the relationship between changes in BNA to symptoms, cognitive performance and vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high school athletes with concussion.


Condition
Mild Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion

Resource links provided by NLM:


Further study details as provided by ElMindA Ltd:

Primary Outcome Measures:
  • Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period [ Time Frame: baseline, 1-7, 8-14, and 15-21 day post-injury intervals ] [ Designated as safety issue: No ]
    To examine prospectively changes in brain network activation (BNA) from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.


Secondary Outcome Measures:
  • Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period [ Time Frame: baseline, 1-7, 8-14, and 15-21 day post-injury intervals ] [ Designated as safety issue: No ]
    To investigate the relationship between changes in BNA to changes in symptoms from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.

  • Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period [ Time Frame: baseline, 1-7, 8-14, and 15-21 day post-injury intervals ] [ Designated as safety issue: No ]
    To investigate the relationship between changes in BNA to changes in cognitive performance from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.

  • Relationship between changes in BNA to changes in vestibular function from baseline over post concussion recovery period [ Time Frame: baseline, 1-7, 8-14, and 15-21 day post-injury intervals ] [ Designated as safety issue: No ]
    To investigate the relationship between changes in BNA to changes in vestibular function from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.


Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
High School Athletes

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

High school (13-18 yrs) athletes from American football, soccer, and lacrosse who meet the inclusion/exclusion criteria will be recruited into the study. We expect that between 10-20 participants will sustain a concussion during the period of the study and complete the post-concussion protocol.

Criteria

Inclusion Criteria:

  • Aged 13-18 years
  • Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments
  • Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)

Exclusion Criteria:

  • Current or history of TBI (i.e., Glasgow Coma Scale <13) or brain surgery
  • Current or history of any psychiatric disorder (except ADD/ADHD), e.g., depression, bipolar disorder, schizophrenic disorder
  • Substance abuse within the last year
  • Current or history of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder
  • Current or history of any Neurological disorder, e.g., epilepsy, seizures
  • History of any medication affecting CNS within the last year, e.g., antidepressants, anticonvulsants, Ritalin, first generation antihistamines, etc.
  • Current or history of Significant sensory deficits such as deafness or blindness
  • Current or history of Clinically significant abnormal laboratory values or ECG
  • A concussion within the last year
  • Current or history of residual symptoms or deficits related to a previous concussion
  • Diagnosis of autistic spectrum disorders, e.g., Asperger's syndrome, High functioning Autism, PDD
  • Currently with lice or open wounds on scalp
  • Long and thick hair that prevents the proper administration of an EEG cap
  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: NCT01673464

Contacts
Contact: Anthony P. Kontos, PhD. 412.432.3725 akontos@pitt.edu

Locations
United States, Pennsylvania
UPMC Sports Medicine Concussion Program Recruiting
Pittsburgh, Pennsylvania, United States, 15203
Contact: Anthony P. Kontos, Ph.D    412-432-3725    akontos@pitt.edu   
Principal Investigator: Anthony P. Kontos, Ph.D         
Sponsors and Collaborators
ElMindA Ltd
  More Information

No publications provided

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT01673464     History of Changes
Other Study ID Numbers: ELM-12
Study First Received: August 21, 2012
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 24, 2014