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

NCT01673464 | Completed

• 1 other identifier: ELM-12
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury

Keywords

mild Traumatic Brain Injury; mTBI; Concussion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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

Study Arms (1)

High School Athletes

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

High school (13-18 yrs) athletes from American football, soccer, and lacrosse who meet the inclusion/exclusion criteria will be recruited into the study. We expect that between 10-20 participants will sustain a concussion during the period of the study and complete the post-concussion protocol.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (1)

UPMC Sports Medicine Concussion Program

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 28, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

US (1)