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

ElMindA Ltd1 site in 1 country126 target enrollmentAugust 2012

ConditionsMild Traumatic Brain Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mild Traumatic Brain Injury
Sponsor: ElMindA Ltd
Enrollment: 126
Locations: 1
Primary Endpoint: Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

June 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

ElMindA Ltd

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

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 Outcomes

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)
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)
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)