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

Sponsor

ElMindA Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01673464

Collaborator

(none)

126

Enrollment

Location

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Traumatic Brain Injury

Study Design

Study Type:

Observational

Actual Enrollment :

126 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
High School Athletes

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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