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

April 8, 2015 updated by: ElMindA Ltd
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15203
        • UPMC Sports Medicine Concussion Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
High School Athletes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 1-7, 8-14, and 15-21 day post-injury intervals

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
baseline, 1-7, 8-14, and 15-21 day post-injury intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ElMindA Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ELM-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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