<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/NCT01671761</url>
  </required_header>
  <id_info>
    <org_study_id>ELM-19</org_study_id>
    <nct_id>NCT01671761</nct_id>
  </id_info>
  <brief_title>Normative Data of Brain Network Activation in Adolescents and Young Adults</brief_title>
  <official_title>Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents and Young Adults</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>
      Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in&#xD;
      two age groups: adolescents and young adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, there is no reliable, practical, and non-invasive method for assessing changes in&#xD;
      electrophysiological activity of the brain associated with brain-related pathologies, e.g.,&#xD;
      concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs),&#xD;
      which are temporal reflections of the neural mass electrical activity of cells in specific&#xD;
      regions of the brain that occur in response to stimuli, may offer such a method, as they&#xD;
      provide both a noninvasive and portable measure of brain function. The ERPs provide excellent&#xD;
      temporal information, but spatial resolution for ERPs has traditionally been limited.&#xD;
      However, by using high-density electroencephalograph (EEG) recording spatial resolution for&#xD;
      ERPs is improved significantly. The paradigm for the current study will combine&#xD;
      neurophysiological knowledge with mathematical signal processing and pattern recognition&#xD;
      methods (BNA) to temporally and spatially map brain function, connectivity and&#xD;
      synchronization.&#xD;
&#xD;
      The need of objective measures that will help the clinician in its decision making in&#xD;
      brain-related pathologies is recognized. BNA is a new imaging modality that has been&#xD;
      developed to fill this gap.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 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>Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data</measure>
    <time_frame>1 year</time_frame>
    <description>The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Healthy Controls</condition>
  <arm_group>
    <arm_group_label>young adults</arm_group_label>
    <description>19-24 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>adolescents</arm_group_label>
    <description>15-18 years old</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Experimental subjects will include males and females recruited from the New York City&#xD;
        metropolitan area, Clinilabs Ltd. Clinical Research's database and from referrals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 15-24 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;
          -  Currently participate in a contact sport (e.g., football, hockey, soccer, rugby,&#xD;
             lacrosse, martial arts).&#xD;
&#xD;
          -  Currently with lice or open wounds on scalp.&#xD;
&#xD;
          -  Any chronic disease as determined by clinical evaluation and medical history.&#xD;
&#xD;
          -  Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder,&#xD;
             etc. as determined by clinical evaluation and the Mini International Neuropsychiatric&#xD;
             Interview (MINI)&#xD;
&#xD;
          -  Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical&#xD;
             evaluation&#xD;
&#xD;
          -  Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc.&#xD;
             as determined by clinical evaluation&#xD;
&#xD;
          -  History of Special education, e.g., reading disorder (dyslexia), writing disorder&#xD;
             (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.&#xD;
&#xD;
          -  History of any medication affecting CNS within the last 3 months, e.g.,&#xD;
             antidepressants, anticonvulsants, psychostimulants, first generation antihistamines,&#xD;
             etc.&#xD;
&#xD;
          -  Substance abuse in the last 3 months.&#xD;
&#xD;
          -  Significant sensory deficits, e.g., deafness or blindness.&#xD;
&#xD;
          -  History of any clinically significant brain trauma as determined by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinilabs, Inc.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</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 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 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>Healthy</keyword>
  <keyword>Control</keyword>
  <!-- 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/NCT01671761
org study id: ELM-19
nct id: NCT01671761
lead sponsor: 
has dmc: No
Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in
      two age groups: adolescents and young adults.
Currently, there is no reliable, practical, and non-invasive method for assessing changes in
      electrophysiological activity of the brain associated with brain-related pathologies, e.g.,
      concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs),
      which are temporal reflections of the neural mass electrical activity of cells in specific
      regions of the brain that occur in response to stimuli, may offer such a method, as they
      provide both a noninvasive and portable measure of brain function. The ERPs provide excellent
      temporal information, but spatial resolution for ERPs has traditionally been limited.
      However, by using high-density electroencephalograph (EEG) recording spatial resolution for
      ERPs is improved significantly. The paradigm for the current study will combine
      neurophysiological knowledge with mathematical signal processing and pattern recognition
      methods (BNA) to temporally and spatially map brain function, connectivity and
      synchronization.

      The need of objective measures that will help the clinician in its decision making in
      brain-related pathologies is recognized. BNA is a new imaging modality that has been
      developed to fill this gap.
observational model: Cohort
time perspective: Prospective
measure: Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
time frame: 1 year
description: The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks
arm group label: young adults
description: 19-24 years old
arm group label: adolescents
description: 15-18 years old
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor