<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/NCT03835962</url>
  </required_header>
  <id_info>
    <org_study_id>NCI_NCClin_002</org_study_id>
    <nct_id>NCT03835962</nct_id>
  </id_info>
  <brief_title>Development of a Reference Interval Database With the NeuroCatch™ Platform</brief_title>
  <official_title>Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NeuroCatch Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NeuroCatch Inc.</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 NeuroCatch Platform™, an investigational medical device system developed by NeuroCatch&#xD;
      Inc., consists of software and hardware that captures brain health information. The platform&#xD;
      intends to provide a quick, portable and easy to use solution for the acquisition, display,&#xD;
      analysis, storage, reporting and management of electroencephalograph (EEG) and event-related&#xD;
      potential (ERP; brain response to a stimulus) information.&#xD;
&#xD;
      The purpose of the study is to understand how the brain responds to sounds and words, and how&#xD;
      this response varies between individuals of different age groups. Interindividual variation&#xD;
      reflects the many different factors which cause results to vary from one individual to&#xD;
      another within a population. The current clinical study aims to establish a reference&#xD;
      interval database of ERPs. These reference intervals will characterize the expected range of&#xD;
      interindividual variability between groups. Reference interval databases provide a tool for&#xD;
      comparing the results from one individual with those from other members of the same age&#xD;
      group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform</measure>
    <time_frame>1 day</time_frame>
    <description>Response size will be measured as amplitude in microvolts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform</measure>
    <time_frame>1 day</time_frame>
    <description>Response timing will be measured as latency in milliseconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collection and evaluation of adverse events and adverse device effects</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluation of safety and tolerability of the NeuroCatch™ Platform device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic indicators (date of birth, sex, level of education, recent sleep, average sleep, fatigue level, recent exercise, recent diet, handedness, first language, medical history, neurological status, and profession)</measure>
    <time_frame>1 day</time_frame>
    <description>Secondary statistical analyses will explore relationships between demographic indicators, medical history, neurological status and ERP measures across the sample and within groups.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Brain Health</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be asked to attend one experimental session. During the session, participants will listen one auditory stimulus sequence including sounds and words while EEG activity is recorded using the NeuroCatch Platform™ device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeuroCatch™ Platform</intervention_name>
    <description>NeuroCatch Platform™ consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP) information.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any sex, at least 8 years of age or older&#xD;
&#xD;
          2. Able to understand the informed consent/assent form, study procedures and willing to&#xD;
             participate in study&#xD;
&#xD;
          3. Able to remain seated and focused for 6 minutes&#xD;
&#xD;
          4. Normal hearing capabilities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or&#xD;
             punctured ear drum)&#xD;
&#xD;
          2. Implanted pacemaker or implanted electrical stimulators&#xD;
&#xD;
          3. Metal or plastic implants in skull&#xD;
&#xD;
          4. Exposed to an investigational drug or device 30 days prior to start in this study, or&#xD;
             concurrent or planned use of investigational drug or device while enrolled in this&#xD;
             study&#xD;
&#xD;
          5. Not proficient in English language&#xD;
&#xD;
          6. Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months&#xD;
&#xD;
          7. If female and of child-bearing potential: pregnant, suspected or planning to become&#xD;
             pregnant or breast-feeding&#xD;
&#xD;
          8. History of seizures&#xD;
&#xD;
          9. Allergy to rubbing alcohol or EEG gel&#xD;
&#xD;
         10. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HealthTech Connex Centre for Neurology Studies</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 0C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03835962
org study id: NCI_NCClin_002
nct id: NCT03835962
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The NeuroCatch Platform™, an investigational medical device system developed by NeuroCatch
      Inc., consists of software and hardware that captures brain health information. The platform
      intends to provide a quick, portable and easy to use solution for the acquisition, display,
      analysis, storage, reporting and management of electroencephalograph (EEG) and event-related
      potential (ERP; brain response to a stimulus) information.

      The purpose of the study is to understand how the brain responds to sounds and words, and how
      this response varies between individuals of different age groups. Interindividual variation
      reflects the many different factors which cause results to vary from one individual to
      another within a population. The current clinical study aims to establish a reference
      interval database of ERPs. These reference intervals will characterize the expected range of
      interindividual variability between groups. Reference interval databases provide a tool for
      comparing the results from one individual with those from other members of the same age
      group.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform
time frame: 1 day
description: Response size will be measured as amplitude in microvolts.
measure: Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform
time frame: 1 day
description: Response timing will be measured as latency in milliseconds.
measure: Collection and evaluation of adverse events and adverse device effects
time frame: 1 day
description: Evaluation of safety and tolerability of the NeuroCatch™ Platform device
measure: Demographic indicators (date of birth, sex, level of education, recent sleep, average sleep, fatigue level, recent exercise, recent diet, handedness, first language, medical history, neurological status, and profession)
time frame: 1 day
description: Secondary statistical analyses will explore relationships between demographic indicators, medical history, neurological status and ERP measures across the sample and within groups.
arm group label: Intervention Arm
arm group type: Experimental
description: All participants will be asked to attend one experimental session. During the session, participants will listen one auditory stimulus sequence including sounds and words while EEG activity is recorded using the NeuroCatch Platform™ device.
intervention type: Device
intervention name: NeuroCatch™ Platform
description: NeuroCatch Platform™ consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP) information.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: Undecided