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

ElMindA

Status: Completed

Conditions: Mild Traumatic Brain Injury

Study type: Observational

Funder types: Industry

Identifiers

NCT01673464

ELM-12

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

126 participants in 1 patient group

High School Athletes