xml: <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/NCT06013566</url>
    </required_header>
    <id_info>
      <org_study_id>2018-10-891-PRO</org_study_id>
      <nct_id>NCT06013566</nct_id>
    </id_info>
    <brief_title>SSVEP Evaluation of Brain Function (PRO)</brief_title>
    <official_title>SSVEP Evaluation of Brain Function (PRO)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Headsafe MFG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Headsafe MFG</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigational device used in this clinical investigation, the Nurochek PRO System&#xD;
        (NCPRO), is a portable electroencephalogram (EEG) headset which delivers a visual stimulus&#xD;
        and measures a VEP. The visual stimulus is delivered to the subjects' eyes via light-emitting&#xD;
        diodes, and the EEG measures the user's visual-evoked potential. This headset communicates&#xD;
        with an application on a computer, which processes the signals and transmits them to a secure&#xD;
        cloud server for analysis and storage of the data. Nurochek PRO is a development of the&#xD;
        previously FDA cleared Nurochek System.&#xD;
  &#xD;
        The primary objective of this clinical investigation was to evaluate the performance of the&#xD;
        investigational device (NCPRO) against clinical diagnosis of detection of mild traumatic&#xD;
        brain injury (mTBI). The primary endpoint outlined for this study was set at the collection&#xD;
        of 100 valid investigational device readings from individuals with concussion and 500 valid&#xD;
        investigational device readings from healthy individuals who have had a plausible mechanism&#xD;
        of sustaining a concussion, but do not have one. Additionally, readings from healthy&#xD;
        individuals are also to be acquired.&#xD;
  &#xD;
        The aim of this study was to collect data from 100 readings from individuals with concussion.&#xD;
        The initial assumption was that sites would provide players pre-season and make players&#xD;
        available for testing post-concussion. In practice, some sites provided player data only&#xD;
        post-concussion event (such as medical clinics). Participants were acquired from sporting&#xD;
        clubs, medical clinicals and schools.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">January 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Steady State Visual Evoked Potential</measure>
      <time_frame>5 days</time_frame>
      <description>A measure of the steady state visual evoked potential (SSVEP) from the device and comparison with a Doctor's diagnosis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recovery from m TBI</measure>
      <time_frame>30 days</time_frame>
      <description>Follow up testing with the investigational device to examine of there is a link between mTBI recovery and investigational device recordings of brain activity.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Mild Traumatic Brain Injury</condition>
    <arm_group>
      <arm_group_label>Baseline</arm_group_label>
      <description>This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Concussed</arm_group_label>
      <description>This cohort contains individuals who have had a concussion, diagnosed by a doctor.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Suspected Concussion</arm_group_label>
      <description>This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SSVEP</intervention_name>
      <description>Non-invasive, non-interventional SSVEP EEG device</description>
      <arm_group_label>Baseline</arm_group_label>
      <arm_group_label>Concussed</arm_group_label>
      <arm_group_label>Suspected Concussion</arm_group_label>
      <other_name>Nurochek PRO</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          As above.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals aged 12 years and older, participating in sport-related activities.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals are excluded if they have a history of seizures, history of epilepsy,&#xD;
               structural brain injuries, legal blindness, or sensitivity to flashing lights.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Craig Donaldson, MBBS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Principal Investigator</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anton Nathanson</last_name>
      <phone>+61 424 831 142</phone>
      <email>anton@team.headsafe.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Headsafe</name>
        <address>
          <city>Sydney</city>
          <country>Australia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anton Nathanson</last_name>
        <phone>+61424831142</phone>
        <email>anton@team.headsafe.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mild Traumatic brain injury</keyword>
    <keyword>Concussion</keyword>
    <keyword>Steady state visual evoked potential</keyword>
    <keyword>Electroencephalography</keyword>
    <keyword>Sports Concussion</keyword>
    <keyword>Sports Medicine</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013566
  org study id: 2018-10-891-PRO
  nct id: NCT06013566
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigational device used in this clinical investigation, the Nurochek PRO System
        (NCPRO), is a portable electroencephalogram (EEG) headset which delivers a visual stimulus
        and measures a VEP. The visual stimulus is delivered to the subjects' eyes via light-emitting
        diodes, and the EEG measures the user's visual-evoked potential. This headset communicates
        with an application on a computer, which processes the signals and transmits them to a secure
        cloud server for analysis and storage of the data. Nurochek PRO is a development of the
        previously FDA cleared Nurochek System.
  
        The primary objective of this clinical investigation was to evaluate the performance of the
        investigational device (NCPRO) against clinical diagnosis of detection of mild traumatic
        brain injury (mTBI). The primary endpoint outlined for this study was set at the collection
        of 100 valid investigational device readings from individuals with concussion and 500 valid
        investigational device readings from healthy individuals who have had a plausible mechanism
        of sustaining a concussion, but do not have one. Additionally, readings from healthy
        individuals are also to be acquired.
  
        The aim of this study was to collect data from 100 readings from individuals with concussion.
        The initial assumption was that sites would provide players pre-season and make players
        available for testing post-concussion. In practice, some sites provided player data only
        post-concussion event (such as medical clinics). Participants were acquired from sporting
        clubs, medical clinicals and schools.
  observational model: Case-Control
  time perspective: Prospective
  measure: Steady State Visual Evoked Potential
  time frame: 5 days
  description: A measure of the steady state visual evoked potential (SSVEP) from the device and comparison with a Doctor's diagnosis.
  measure: Recovery from m TBI
  time frame: 30 days
  description: Follow up testing with the investigational device to examine of there is a link between mTBI recovery and investigational device recordings of brain activity.
  arm group label: Baseline
  description: This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season
  arm group label: Concussed
  description: This cohort contains individuals who have had a concussion, diagnosed by a doctor.
  arm group label: Suspected Concussion
  description: This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion.
  intervention type: Device
  intervention name: SSVEP
  description: Non-invasive, non-interventional SSVEP EEG device
  arm group label: Baseline
  arm group label: Concussed
  arm group label: Suspected Concussion
  other name: Nurochek PRO
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Craig Donaldson, MBBS
  role: Principal Investigator
  affiliation: Principal Investigator
  last name: Anton Nathanson
  phone: +61 424 831 142
  email: anton@team.headsafe.com
  facility: 
  status: Recruiting
  contact: 
  country: Australia
  responsible party type: Sponsor
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  mesh term: Brain Concussion
  sharing ipd: No