<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/NCT03249675</url>
  </required_header>
  <id_info>
    <org_study_id>ELM 48</org_study_id>
    <nct_id>NCT03249675</nct_id>
  </id_info>
  <brief_title>Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults</brief_title>
  <official_title>Clinical Trial Protocol for the Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ElMindA Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ElMindA Ltd</source>
  <oversight_info>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Concussion is widely recognized as a major public health concern in the United States and&#xD;
      worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4&#xD;
      patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS&#xD;
      diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked&#xD;
      response potential analysis have led to a novel technique for assessing brain network&#xD;
      activation (BNA) patterns. The purpose of this study is to explore the use of BNA in&#xD;
      individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent&#xD;
      injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mild traumatic brain injury, also known as concussion, occurs commonly in sport. The Centers&#xD;
      for Disease Control and Prevention estimate that as many as 3.8 million sport-related&#xD;
      concussions occur annually in the United States. Although many concussions resolve completely&#xD;
      and spontaneously, almost 1 in 4 patients will go on to experience post-concussion syndrome&#xD;
      (PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Concurrently,&#xD;
      recent advances in EEG evoked response potential analysis have led to a novel technique for&#xD;
      assessing brain network activation (BNA) patterns. The purpose of this study is to explore&#xD;
      the use of BNA in individuals who are diagnosed with PCS or have the risk of experiencing PCS&#xD;
      due to a recent injury.&#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 which&#xD;
      can assist in patient evaluation and management. The analysis is done in two separate&#xD;
      processes which are entirely separate and are performed independently of one another. First&#xD;
      EEG data are recorded and analyzed from a group, or several groups, of subjects to establish&#xD;
      a set of group patterns which characterized the brain network activity of the group. Second,&#xD;
      EEG data from a single subject are processed to enable subject evaluation, as compared to the&#xD;
      established group patterns. This individual analysis is the basis of the BNA scores computed&#xD;
      for an individual subject.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      • Exploratory (e.g. Hypothesis-generating) study designed to collect data that will aid in&#xD;
      future understanding of the relationship between Post Concussion Syndrome and&#xD;
      Electrophysiology. The results are primarily intended for scientific inquiry and development&#xD;
      purposes.&#xD;
&#xD;
      Additional objectives:&#xD;
&#xD;
        -  Exploring the relationship between the characteristics of early/acute stage Mild&#xD;
           Traumatic Brain Injury and the subsequent development of PCS&#xD;
&#xD;
        -  Collecting electrophysiological and clinical data that will serve as the basis for&#xD;
           athlete brain health case studies.&#xD;
&#xD;
      Arm 1: Study staff will contact subjects tested in the past with BNA and were diagnosed with&#xD;
      Post-Concussion Syndrome at their medical facility.&#xD;
&#xD;
      Arm 2: Eligible subjects treated at the study medical facility for acute concussion or Post&#xD;
      Concussion Syndrome will be approached by the study staff.&#xD;
&#xD;
      Interested volunteers will complete a brief initial in person or phone consultation with a&#xD;
      member of the study team and those who meet eligibility criteria and wish to participate will&#xD;
      be invited for a study visit in the testing facility. During this visit, a member of the&#xD;
      study team will describe the study in greater detail, verify subject eligibility, obtain&#xD;
      informed written consent/assent for study participation, and record relevant demographic,&#xD;
      medical history information, concussion history and clinical assessment questioners as&#xD;
      provided by the subject or as available from subject's medical records. The subject will then&#xD;
      have the EEG electrode cap placed on their head and will undergo the BNA test after a brief&#xD;
      training and instructional session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participant were enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Developing a BNA database for concuss population.</measure>
    <time_frame>This study duration is 18 months</time_frame>
    <description>Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Concussion, Brain</condition>
  <arm_group>
    <arm_group_label>ARM 1</arm_group_label>
    <description>ARM 1: Retrospective Arm: Subjects tested with BNA in the past and have been diagnosed by their physician as having Post Concussive Syndrome. Study staff will contact the subjects and obtain Informed Consent. Study physicians will then review both BNA data and Clinical data. All relevant clinical data and all available BNA data will be shared with ElMindA. Subjects may be invited for an additional BNA follow up as part of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM 2</arm_group_label>
    <description>ARM 2: Subjects will be prospectively enrolled in the study at the following time points when available:&#xD;
Acute: within 2 weeks of injury&#xD;
PCS: Subjects which sustained a concussion in the past 3 months or more, and are still experiencing symptoms related to the injury</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adolescents, young adults and adults of both genders.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females Aged 12-50&#xD;
&#xD;
          -  Willingness to participate in the study and the ability to give informed assent (for&#xD;
             children) and/or consent (for the parent of a minor or adults aged 18 years of age or&#xD;
             older for themselves).&#xD;
&#xD;
          -  Subjects that are or were diagnosed with mTBI according to the standard diagnostic&#xD;
             procedures at the investigational site in a timeframe that meets enrollment criteria.&#xD;
&#xD;
          -  Subjects that are experiencing symptoms of concussion or Post-concussion Syndrome at&#xD;
             the time of their initial test session.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects that have undergone neuroimaging with identification of intracranial&#xD;
             structural pathology.&#xD;
&#xD;
          -  Self-reported history of central nervous system injury other than mTBI, or disease&#xD;
             (examples will include, but will not be limited to, moderate or severe traumatic brain&#xD;
             injury (TBI with a Glasgow Coma Scale &lt; 13) epilepsy, seizures, brain surgery)&#xD;
&#xD;
          -  Neuropsychological disorder such as autistic spectrum disorder&#xD;
&#xD;
          -  Any history of a learning disability (examples include, but will not be limited to,&#xD;
             dyslexia, dysgraphia, dyscalculia, or a nonverbal learning disorder)&#xD;
&#xD;
          -  Use of any medication affecting central nervous system (CNS) in the past 3 months&#xD;
             prior to their BNA (i.e. antidepressants, anticonvulsants, psychostimulants, first&#xD;
             generation antihistamines, etc.)&#xD;
&#xD;
          -  Active head lice infection&#xD;
&#xD;
          -  Open scalp wound&#xD;
&#xD;
          -  baldness, dread locks or hair that is otherwise sufficiently long and thick so as to&#xD;
             preclude appropriate scalp electrode cap fit&#xD;
&#xD;
          -  Deafness, and/or blindness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Kutcher, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>The Sports Neurology Clinic at The CORE Institute</name>
      <address>
        <city>Brighton</city>
        <state>Michigan</state>
        <zip>48114</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 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 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 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mild Traumatic Brain Injury</keyword>
  <keyword>Concussion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03249675
org study id: ELM 48
nct id: NCT03249675
lead sponsor: 
is us export: No
Concussion is widely recognized as a major public health concern in the United States and
      worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4
      patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS
      diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked
      response potential analysis have led to a novel technique for assessing brain network
      activation (BNA) patterns. The purpose of this study is to explore the use of BNA in
      individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent
      injury.
Mild traumatic brain injury, also known as concussion, occurs commonly in sport. The Centers
      for Disease Control and Prevention estimate that as many as 3.8 million sport-related
      concussions occur annually in the United States. Although many concussions resolve completely
      and spontaneously, almost 1 in 4 patients will go on to experience post-concussion syndrome
      (PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Concurrently,
      recent advances in EEG evoked response potential analysis have led to a novel technique for
      assessing brain network activation (BNA) patterns. The purpose of this study is to explore
      the use of BNA in individuals who are diagnosed with PCS or have the risk of experiencing PCS
      due to a recent injury.

      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 which
      can assist in patient evaluation and management. The analysis is done in two separate
      processes which are entirely separate and are performed independently of one another. First
      EEG data are recorded and analyzed from a group, or several groups, of subjects to establish
      a set of group patterns which characterized the brain network activity of the group. Second,
      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.

      Primary Objective:

      • Exploratory (e.g. Hypothesis-generating) study designed to collect data that will aid in
      future understanding of the relationship between Post Concussion Syndrome and
      Electrophysiology. The results are primarily intended for scientific inquiry and development
      purposes.

      Additional objectives:

        -  Exploring the relationship between the characteristics of early/acute stage Mild
           Traumatic Brain Injury and the subsequent development of PCS

        -  Collecting electrophysiological and clinical data that will serve as the basis for
           athlete brain health case studies.

      Arm 1: Study staff will contact subjects tested in the past with BNA and were diagnosed with
      Post-Concussion Syndrome at their medical facility.

      Arm 2: Eligible subjects treated at the study medical facility for acute concussion or Post
      Concussion Syndrome will be approached by the study staff.

      Interested volunteers will complete a brief initial in person or phone consultation with a
      member of the study team and those who meet eligibility criteria and wish to participate will
      be invited for a study visit in the testing facility. During this visit, a member of the
      study team will describe the study in greater detail, verify subject eligibility, obtain
      informed written consent/assent for study participation, and record relevant demographic,
      medical history information, concussion history and clinical assessment questioners as
      provided by the subject or as available from subject's medical records. The subject will then
      have the EEG electrode cap placed on their head and will undergo the BNA test after a brief
      training and instructional session.
observational model: Cohort
time perspective: Prospective
measure: Developing a BNA database for concuss population.
time frame: This study duration is 18 months
description: Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
arm group label: ARM 1
description: ARM 1: Retrospective Arm: Subjects tested with BNA in the past and have been diagnosed by their physician as having Post Concussive Syndrome. Study staff will contact the subjects and obtain Informed Consent. Study physicians will then review both BNA data and Clinical data. All relevant clinical data and all available BNA data will be shared with ElMindA. Subjects may be invited for an additional BNA follow up as part of the study.
arm group label: ARM 2
description: ARM 2: Subjects will be prospectively enrolled in the study at the following time points when available:
Acute: within 2 weeks of injury
PCS: Subjects which sustained a concussion in the past 3 months or more, and are still experiencing symptoms related to the injury
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Kutcher, MD
role: Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Concussion