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Completed

NCT Number: NCT01673464

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

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Sports Medicine Concussion Program

Pittsburgh, Pennsylvania, 15203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period

    Time frame: 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.

  2. Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period

    Time frame: 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.

  3. Relationship between changes in BNA to changes in vestibular function from baseline over post concussion recovery period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ElMindA Ltd

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 28, 2012
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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