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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673464
• Other study ID #: ELM-12
• Status: Completed
• Phase: N/A
• First received: August 21, 2012
• Last updated: April 8, 2015
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: ElMindA Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Mild Traumatic Brain Injury

Locations

Country	Name	City	State
United States	UPMC Sports Medicine Concussion Program	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No