<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01673464</url>
  </required_header>
  <id_info>
    <org_study_id>ELM-12</org_study_id>
    <nct_id>NCT01673464</nct_id>
  </id_info>
  <brief_title>A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion</brief_title>
  <official_title>A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ElMindA Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ElMindA Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to prospectively examine changes in Brain Network&#xD;
      Activation(BNA)following concussion in high school athletes. In addition, the study will&#xD;
      examine the relationship between changes in BNA to symptoms, cognitive performance and&#xD;
      vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high&#xD;
      school athletes with concussion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period</measure>
    <time_frame>baseline, 1-7, 8-14, and 15-21 day post-injury intervals</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period</measure>
    <time_frame>baseline, 1-7, 8-14, and 15-21 day post-injury intervals</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period</measure>
    <time_frame>baseline, 1-7, 8-14, and 15-21 day post-injury intervals</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between changes in BNA to changes in vestibular function from baseline over post concussion recovery period</measure>
    <time_frame>baseline, 1-7, 8-14, and 15-21 day post-injury intervals</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">126</enrollment>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>High School Athletes</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        High school (13-18 yrs) athletes from American football, soccer, and lacrosse who meet the&#xD;
        inclusion/exclusion criteria will be recruited into the study. We expect that between 10-20&#xD;
        participants will sustain a concussion during the period of the study and complete the&#xD;
        post-concussion protocol.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 13-18 years&#xD;
&#xD;
          -  Able to speak, read and understand English sufficiently to understand the nature of&#xD;
             the study, and to allow completion of all study assessments&#xD;
&#xD;
          -  Willingness to participate and able to give informed assent (child) and/or consent&#xD;
             (parent for minors or adult 18+ years of age for self)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or history of TBI (i.e., Glasgow Coma Scale &lt;13) or brain surgery&#xD;
&#xD;
          -  Current or history of any psychiatric disorder (except ADD/ADHD), e.g., depression,&#xD;
             bipolar disorder, schizophrenic disorder&#xD;
&#xD;
          -  Substance abuse within the last year&#xD;
&#xD;
          -  Current or history of Special education, e.g., reading disorder (dyslexia), writing&#xD;
             disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder&#xD;
&#xD;
          -  Current or history of any Neurological disorder, e.g., epilepsy, seizures&#xD;
&#xD;
          -  History of any medication affecting CNS within the last year, e.g., antidepressants,&#xD;
             anticonvulsants, Ritalin, first generation antihistamines, etc.&#xD;
&#xD;
          -  Current or history of Significant sensory deficits such as deafness or blindness&#xD;
&#xD;
          -  Current or history of Clinically significant abnormal laboratory values or ECG&#xD;
&#xD;
          -  A concussion within the last year&#xD;
&#xD;
          -  Current or history of residual symptoms or deficits related to a previous concussion&#xD;
&#xD;
          -  Diagnosis of autistic spectrum disorders, e.g., Asperger's syndrome, High functioning&#xD;
             Autism, PDD&#xD;
&#xD;
          -  Currently with lice or open wounds on scalp&#xD;
&#xD;
          -  Long and thick hair that prevents the proper administration of an EEG cap&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UPMC Sports Medicine Concussion Program</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>April 8, 2015</last_update_submitted>
  <last_update_submitted_qc>April 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mild Traumatic Brain Injury</keyword>
  <keyword>mTBI</keyword>
  <keyword>Concussion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01673464
org study id: ELM-12
nct id: NCT01673464
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
arm group label: High School Athletes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion