<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/NCT04504890</url>
  </required_header>
  <id_info>
    <org_study_id>EYESYNCOBIADHD2020</org_study_id>
    <nct_id>NCT04504890</nct_id>
  </id_info>
  <brief_title>Ocular-vestibular Biomarker Identification for ADHD</brief_title>
  <official_title>Ocular-vestibular Biomarker Identification for ADHD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sync-Think, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sutter Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sync-Think, 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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study intends to establish a relationship between oculovestibular eye tracking measures,&#xD;
      measures of ADHD, and medication prescribed for ADHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will use a predictive visual tracking paradigm (SyncThink EYE-SYNC eye tracking&#xD;
      paradigm) to dynamically capture the participants' attentional state. It will examine the&#xD;
      validity of the eye tracking paradigm in identifying the disruption in attentional networks&#xD;
      caused by ADHD by examining the association between eye tracking performances and&#xD;
      well-established standardized measures of ADHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Anticipated">October 5, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 5, 2021</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>Eye Tracking and ADHD measure correlation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eye Tracking ADHD Diagnostic ROC</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Specific eye tracking parameters will be compared to determine which have the greatest diagnostic utility. Supervised machine learning models will be generated and optimized ROC AUC for both children and adults using eye tracking parameters as input and CAARS indices, CBRS indices, and clinical diagnosis as outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MANCOVA Eye Tracking in ADHD Treatment Population</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Repeated measures multivariate analysis of covariance (MANCOVA) will be used to compare eye tracking performance over time in adults and children with ADHD (medicated and unmedicated)</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">240</enrollment>
  <condition>ADHD - Combined Type</condition>
  <condition>ADHD</condition>
  <condition>ADHD Predominantly Inattentive Type</condition>
  <condition>ADHD, Predominantly Hyperactive - Impulsive</condition>
  <arm_group>
    <arm_group_label>Adults - Diagnosis</arm_group_label>
    <description>Adults seeking treatment for an attention-related disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adults - Prescribed</arm_group_label>
    <description>Adults who have been diagnosed with ADHD and prescribed medication treatment for the disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children - Diagnosis</arm_group_label>
    <description>Children seeking treatment for an attention-related disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children - Prescribed</arm_group_label>
    <description>Children who have been diagnosed with ADHD and prescribed medication treatment for the disorder</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EYE-SYNC</intervention_name>
    <description>Nystagmograph used to measure eye movement</description>
    <arm_group_label>Adults - Diagnosis</arm_group_label>
    <arm_group_label>Adults - Prescribed</arm_group_label>
    <arm_group_label>Children - Diagnosis</arm_group_label>
    <arm_group_label>Children - Prescribed</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children and adults seeking diagnosis and/or treatment for attention-related disorder.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women ages 6-70 seeking evaluation and treatment for ADHD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of a neurological condition including the following: stroke,&#xD;
             multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other&#xD;
             major neurological condition.&#xD;
&#xD;
               -  Clinical diagnosis of any of the following eye-sight abnormalities: uncorrected&#xD;
                  amblyopia, uncorrected myopia, uncorrected presbyopia, uncorrected farsightedness&#xD;
                  or uncorrected Astigmatism.&#xD;
&#xD;
               -  Psychiatric history with any of the following:&#xD;
&#xD;
          -  LIFETIME: Clinical diagnosis of a psychotic disorder; bipolar disorder&#xD;
&#xD;
          -  LAST YEAR: Clinical diagnosis of major depressive disorder; PTSD; clinical diagnosis&#xD;
             of substance abuse disorder; major anxiety disorder&#xD;
&#xD;
               -  Use of a psychotropic medication&#xD;
&#xD;
               -  Impairment of cranial nerves II-VI&#xD;
&#xD;
               -  Participants who receive a 'Poor' or 'Fair' eye tracking quality result on either&#xD;
                  their baseline or follow-up evaluations will be excluded from analysis. Subjects&#xD;
                  may not repeat participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Benjamin Cheyette, M.D.,Ph.D.</last_name>
    <phone>650.278.1814</phone>
    <email>cheyetbr@sutterhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation - San Carlos Center</name>
      <address>
        <city>San Carlos</city>
        <state>California</state>
        <zip>94070</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Cheyette, M.D., Ph.D.</last_name>
      <phone>650-278-1814</phone>
      <email>cheyetbr@sutterhealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Sarah Cheyette, M.D.</last_name>
      <email>CheyetS@sutterhealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Benjamin Cheyette, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sarah Cheyette, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>EYE-SYNC</keyword>
  <keyword>eye tracking</keyword>
  <keyword>oculomotor</keyword>
  <keyword>vestibular</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</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/NCT04504890
org study id: EYESYNCOBIADHD2020
nct id: NCT04504890
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study intends to establish a relationship between oculovestibular eye tracking measures,
      measures of ADHD, and medication prescribed for ADHD.
This study will use a predictive visual tracking paradigm (SyncThink EYE-SYNC eye tracking
      paradigm) to dynamically capture the participants' attentional state. It will examine the
      validity of the eye tracking paradigm in identifying the disruption in attentional networks
      caused by ADHD by examining the association between eye tracking performances and
      well-established standardized measures of ADHD.
observational model: Cohort
time perspective: Prospective
measure: Eye Tracking and ADHD measure correlation
time frame: through study completion, an average of 1 year
description: Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables
measure: Eye Tracking ADHD Diagnostic ROC
time frame: through study completion, an average of 1 year
description: Specific eye tracking parameters will be compared to determine which have the greatest diagnostic utility. Supervised machine learning models will be generated and optimized ROC AUC for both children and adults using eye tracking parameters as input and CAARS indices, CBRS indices, and clinical diagnosis as outcomes
measure: MANCOVA Eye Tracking in ADHD Treatment Population
time frame: through study completion, an average of 1 year
description: Repeated measures multivariate analysis of covariance (MANCOVA) will be used to compare eye tracking performance over time in adults and children with ADHD (medicated and unmedicated)
arm group label: Adults - Diagnosis
description: Adults seeking treatment for an attention-related disorder
arm group label: Adults - Prescribed
description: Adults who have been diagnosed with ADHD and prescribed medication treatment for the disorder
arm group label: Children - Diagnosis
description: Children seeking treatment for an attention-related disorder
arm group label: Children - Prescribed
description: Children who have been diagnosed with ADHD and prescribed medication treatment for the disorder
intervention type: Device
intervention name: EYE-SYNC
description: Nystagmograph used to measure eye movement
arm group label: Adults - Diagnosis
arm group label: Adults - Prescribed
arm group label: Children - Diagnosis
arm group label: Children - Prescribed
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Cheyette, M.D.,Ph.D.
phone: 650.278.1814
email: cheyetbr@sutterhealth.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: No