<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/NCT03265912</url>
  </required_header>
  <id_info>
    <org_study_id>ELM-36</org_study_id>
    <nct_id>NCT03265912</nct_id>
  </id_info>
  <brief_title>Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment</brief_title>
  <official_title>Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment - A GE Healthcare Companion Study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ElMindA Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ElMindA Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      mTBI is widely recognized as a major public health concern in the United States and&#xD;
      worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every&#xD;
      concussion. Recent advances in EEG evoked response potential analysis have led to a novel&#xD;
      technique for assessing brain network activation (BNA) patterns. This study purpose is to&#xD;
      study this BNA technology in individuals who have sustained a concussion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport and&#xD;
      Motor Vehicle accidents. The Centers for Disease Control and Prevention estimate that as many&#xD;
      as 3.8 million sport-related concussions occur annually in the United States. Despite ongoing&#xD;
      research, there is no highly sensitive clinical test for cognitive function that can be&#xD;
      rapidly applied in a sporting environment. This makes the clinical diagnosis of concussion&#xD;
      particularly difficult, as the clinical presentation of concussion is highly variable with&#xD;
      symptoms often evolving over time. Furthermore, with less than 10% of concussions resulting&#xD;
      in loss of consciousness, self-reported symptom presence may be the only initial evidence of&#xD;
      a concussion. These factors make concussion a challenging injury to diagnose. Given the&#xD;
      variability in concussion presentations, there is no single test that can diagnose a&#xD;
      concussion.&#xD;
&#xD;
      ElMindA, the sponsor of this study, has developed a novel method to automatically reveal&#xD;
      functional networks of brain activity based on analysis of EEG Event Related Potential (ERP)&#xD;
      data. This technological platform is capable of providing new metrics of brain function that&#xD;
      can assist in patient evaluation and management. The analysis is done in two separate&#xD;
      processes that are entirely separate and are performed independently of one another.&#xD;
      Reference Brain Network Models of EEG data were recorded and analyzed from several groups of&#xD;
      subjects to establish a set of group patterns that characterized the brain network activity&#xD;
      of the group. EEG data from a single subject are processed to enable subject evaluation, as&#xD;
      compared to the established group patterns. This individual analysis is the basis of the BNA&#xD;
      scores computed for an individual subject.&#xD;
&#xD;
      Therefore, this investigation is designed to evaluate the clinical utility of ElMindA's BNA&#xD;
      scores in detecting and managing concussive injuries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 26, 2017</start_date>
  <completion_date type="Actual">January 16, 2018</completion_date>
  <primary_completion_date type="Actual">January 16, 2018</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>Assess the BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.</measure>
    <time_frame>This study duration is 12 months</time_frame>
    <description>Functional networks of brain activity is measured using analysis of EEG Event Related Potential (ERP) data. Clinical assessments battery will be utilized in order to examine different sets of BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Concussion, Mild</condition>
  <condition>TBI (Traumatic Brain Injury)</condition>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Mild Traumatic Brain Injury</arm_group_label>
    <description>Subjects enrolled in the GE healthcare study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), mTBI (Mild Traumatic Brain Injury) patient group also called as Arm 1 in this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Mild Traumatic Brain Injury</arm_group_label>
    <description>Subjects enrolled in the GE healthcare study, Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), non-TBI (Non Mild Traumatic Brain Injury) patients also called as Arm 2 in this study.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adolescents, young adults and adults of both genders, enrolled in Advanced MRI Applications&#xD;
        for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2) Age range: 15-50 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in Arm 1 -mTBI group in the GE study: Advanced MRI Applications for Mild&#xD;
             Traumatic Brain Injury-Phase 2 study&#xD;
&#xD;
          -  Enrolled in Arm 2 -non TBI group in the GE study: Advanced MRI Applications for Mild&#xD;
             Traumatic Brain Injury-Phase 2 study&#xD;
&#xD;
          -  Males and females Aged 15-50&#xD;
&#xD;
          -  Willingness to participate in the companion study and the ability to give informed&#xD;
             assent (for children) and/or consent (for the parent of a minor or adults aged 18&#xD;
             years of age or older for themselves).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hair types which might preclude appropriate scalp electrode cap fit. E.g: dread locks,&#xD;
             corn rows etc.&#xD;
&#xD;
          -  Significant sensory deficit e.g.: Deafness, and/or blindness&#xD;
&#xD;
          -  Open scalp wound&#xD;
&#xD;
          -  Active head lice infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hospital for Special surery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 26, 2018</last_update_submitted>
  <last_update_submitted_qc>September 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <mesh_term>Wounds and Injuries</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/NCT03265912
org study id: ELM-36
nct id: NCT03265912
lead sponsor: 
collaborator: 
is fda regulated drug: No
mTBI is widely recognized as a major public health concern in the United States and
      worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every
      concussion. Recent advances in EEG evoked response potential analysis have led to a novel
      technique for assessing brain network activation (BNA) patterns. This study purpose is to
      study this BNA technology in individuals who have sustained a concussion.
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport and
      Motor Vehicle accidents. The Centers for Disease Control and Prevention estimate that as many
      as 3.8 million sport-related concussions occur annually in the United States. Despite ongoing
      research, there is no highly sensitive clinical test for cognitive function that can be
      rapidly applied in a sporting environment. This makes the clinical diagnosis of concussion
      particularly difficult, as the clinical presentation of concussion is highly variable with
      symptoms often evolving over time. Furthermore, with less than 10% of concussions resulting
      in loss of consciousness, self-reported symptom presence may be the only initial evidence of
      a concussion. These factors make concussion a challenging injury to diagnose. Given the
      variability in concussion presentations, there is no single test that can diagnose a
      concussion.

      ElMindA, the sponsor of this study, has developed a novel method to automatically reveal
      functional networks of brain activity based on analysis of EEG Event Related Potential (ERP)
      data. This technological platform is capable of providing new metrics of brain function that
      can assist in patient evaluation and management. The analysis is done in two separate
      processes that are entirely separate and are performed independently of one another.
      Reference Brain Network Models of EEG data were recorded and analyzed from several groups of
      subjects to establish a set of group patterns that characterized the brain network activity
      of the group. EEG data from a single subject are processed to enable subject evaluation, as
      compared to the established group patterns. This individual analysis is the basis of the BNA
      scores computed for an individual subject.

      Therefore, this investigation is designed to evaluate the clinical utility of ElMindA's BNA
      scores in detecting and managing concussive injuries.
observational model: Cohort
time perspective: Prospective
measure: Assess the BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.
time frame: This study duration is 12 months
description: Functional networks of brain activity is measured using analysis of EEG Event Related Potential (ERP) data. Clinical assessments battery will be utilized in order to examine different sets of BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.
arm group label: Mild Traumatic Brain Injury
description: Subjects enrolled in the GE healthcare study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), mTBI (Mild Traumatic Brain Injury) patient group also called as Arm 1 in this study.
arm group label: Non Mild Traumatic Brain Injury
description: Subjects enrolled in the GE healthcare study, Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), non-TBI (Non Mild Traumatic Brain Injury) patients also called as Arm 2 in this study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 50 Years
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries