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

NCT ID: NCT01673464

Last Updated: 2015-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High School Athletes

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ElMindA Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UPMC Sports Medicine Concussion Program

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ELM-12

Identifier Type: -

Identifier Source: org_study_id

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