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

Completed

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT01673464
• Lead Sponsor: ElMindA Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period	baseline, 1-7, 8-14, and 15-21 day post-injury intervals	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	baseline, 1-7, 8-14, and 15-21 day post-injury intervals	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.
Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period	baseline, 1-7, 8-14, and 15-21 day post-injury intervals	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.

Trial Locations

Locations (1)

UPMC Sports Medicine Concussion Program; 🇺🇸 Pittsburgh, Pennsylvania, United States