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

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.

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15203
      • UPMC Sports Medicine Concussion Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
High School Athletes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period	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.	baseline, 1-7, 8-14, and 15-21 day post-injury intervals

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period	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.	baseline, 1-7, 8-14, and 15-21 day post-injury intervals
Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period	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.	baseline, 1-7, 8-14, and 15-21 day post-injury intervals
Relationship between changes in BNA to changes in vestibular function from baseline over post concussion recovery period	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.	baseline, 1-7, 8-14, and 15-21 day post-injury intervals

Collaborators and Investigators

• Sponsor: ElMindA Ltd

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (Estimate): August 28, 2012

Study Record Updates

• Last Update Posted (Estimate): April 9, 2015
• Last Update Submitted That Met QC Criteria: April 8, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: mild Traumatic Brain Injury; mTBI; Concussion
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: ELM-12