<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/NCT04439656</url>
  </required_header>
  <id_info>
    <org_study_id>DASEY</org_study_id>
    <nct_id>NCT04439656</nct_id>
  </id_info>
  <brief_title>Detecting Absence Seizures Using Eye Tracking</brief_title>
  <official_title>Detecting Absence Seizures Using Eye Tracking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rachel Kuperman</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Orange County</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eysz, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to develop a comfortable system that uses a wearable eye-tracker&#xD;
      similar to eyeglasses to assist people with epilepsy in counting and measuring the severity&#xD;
      of seizures. Participants will wear an eye-tracker during a routine EEG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Seizures can be difficult to detect outside of the hospital even with careful observation by&#xD;
      a caregiver. EEG is the best method that we have to detect seizures- but it is uncomfortable&#xD;
      for long term use outside of the hospital. The goal of this study is to develop a comfortable&#xD;
      system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy&#xD;
      in counting and measuring the severity of seizures. People participating in this study will&#xD;
      have a routine EEG performed while an eye tracker measures eye movements. After the EEG is&#xD;
      complete the researchers will compare the eye movements to the EEG to develop a software&#xD;
      program that can detect seizures from eye movements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">June 28, 2022</completion_date>
  <primary_completion_date type="Actual">June 28, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Eysz algorithm to detect absence seizures</measure>
    <time_frame>1 hour</time_frame>
    <description>EEG is burdensome and limited. The current accepted method of counting seizures is observation which fails to identify &gt; 50% of seizures. The goal is to validate the Eysz absence seizure detection algorithm and show significant improvement over current standard of care</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Epilepsy, Generalized</condition>
  <condition>Absence Epilepsy</condition>
  <condition>Absence Seizures</condition>
  <condition>Seizures</condition>
  <condition>Seizure Disorder</condition>
  <arm_group>
    <arm_group_label>Absence Seizures</arm_group_label>
    <description>Participants with absence seizures will have their eye movements compared to the EEG recording.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Eye movement analysis</intervention_name>
    <description>Eye movements will be analyzed to identify if seizures are present and compared to the EEG read</description>
    <arm_group_label>Absence Seizures</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children or adults with absence seizures.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated informed consent form- per local IRB&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures including the clicker test and&#xD;
             availability for the duration of the study&#xD;
&#xD;
          3. Male or female, aged 4-100&#xD;
&#xD;
          4. Experience known typical absence seizures as defined by the ILAE 2017 classification&#xD;
             or referred to EEG lab for staring spell or concern for absence seizure&#xD;
&#xD;
             a. This will allow for inclusion of children and adults across the entire spectrum of&#xD;
             disease states including new diagnosis (medication naive), medication responsive and&#xD;
             non-medication responsive&#xD;
&#xD;
          5. Scheduled for clinical EEG observation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Intolerant of wearing or unable to wear the eyeglasses&#xD;
&#xD;
          2. Autism or other developmental disorder that the PI thinks will interfere with data&#xD;
             collection&#xD;
&#xD;
          3. History of aggression that the PI thinks will interfere with data collection&#xD;
&#xD;
          4. History of not tolerating EEG that the PI thinks will interfere with data collection&#xD;
&#xD;
          5. Unable to give consent (for individuals ≥ 18 years old) unless they have an adult with&#xD;
             power of attorney to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Kuperman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eysz, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital, San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Child Neurology</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Eysz, Inc.</investigator_affiliation>
    <investigator_full_name>Rachel Kuperman</investigator_full_name>
    <investigator_title>Director, Clinical Research</investigator_title>
  </responsible_party>
  <keyword>eye movements</keyword>
  <keyword>seizure detection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Epilepsy, Absence</mesh_term>
    <mesh_term>Epilepsy, Generalized</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04439656
org study id: DASEY
nct id: NCT04439656
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The goal of this study is to develop a comfortable system that uses a wearable eye-tracker
      similar to eyeglasses to assist people with epilepsy in counting and measuring the severity
      of seizures. Participants will wear an eye-tracker during a routine EEG.
Seizures can be difficult to detect outside of the hospital even with careful observation by
      a caregiver. EEG is the best method that we have to detect seizures- but it is uncomfortable
      for long term use outside of the hospital. The goal of this study is to develop a comfortable
      system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy
      in counting and measuring the severity of seizures. People participating in this study will
      have a routine EEG performed while an eye tracker measures eye movements. After the EEG is
      complete the researchers will compare the eye movements to the EEG to develop a software
      program that can detect seizures from eye movements.
observational model: Other
time perspective: Other
measure: Eysz algorithm to detect absence seizures
time frame: 1 hour
description: EEG is burdensome and limited. The current accepted method of counting seizures is observation which fails to identify > 50% of seizures. The goal is to validate the Eysz absence seizure detection algorithm and show significant improvement over current standard of care
arm group label: Absence Seizures
description: Participants with absence seizures will have their eye movements compared to the EEG recording.
intervention type: Diagnostic Test
intervention name: Eye movement analysis
description: Eye movements will be analyzed to identify if seizures are present and compared to the EEG read
arm group label: Absence Seizures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 100 Years
healthy volunteers: No
last name: Rachel Kuperman, MD
role: Principal Investigator
affiliation: Eysz, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Eysz, Inc.
investigator full name: Rachel Kuperman
investigator title: Director, Clinical Research
mesh term: Epilepsy
mesh term: Seizures
mesh term: Epilepsy, Absence
mesh term: Epilepsy, Generalized
sharing ipd: No