<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/NCT04445116</url>
  </required_header>
  <id_info>
    <org_study_id>20-00634</org_study_id>
    <nct_id>NCT04445116</nct_id>
  </id_info>
  <brief_title>Endeavor™ in Pediatric MS</brief_title>
  <acronym>Akili</acronym>
  <official_title>A Study of Endeavor™, a Video-Game Based Cognitive Remediation, in the Pediatric Multiple Sclerosis (MS) Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the feasibility of using an Endeavor™ application as a treatment&#xD;
      modality for cognitive impairments in the pediatric MS population. Participants will be asked&#xD;
      to undergo a hour-long baseline evaluation, followed by at-home Endeavor™ application&#xD;
      sessions. Subjects will complete the User Experience Feedback Form weekly on REDCap and at&#xD;
      the end of the study. They will undergo another hour-long follow-up evaluation at the end of&#xD;
      the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Duration of subject participation in this study is anticipated to take 3-4 months. After&#xD;
      consent/assent, participants will complete an one hour-long baseline study visit in-person at&#xD;
      the MSCCC, or through a video visit. During this visit, participants will complete a&#xD;
      neuropsychological evaluation and baseline study surveys and get trained on the use of the&#xD;
      Endeavor™ video game. Participants will then be instructed to target a completion of at-home&#xD;
      game play 5 days a week, for a total period of 8 weeks, using their own iOS mobile device, or&#xD;
      a study-provided device if needed, approximately 25-30 minutes each day. Subjects will be&#xD;
      instructed to complete the User Experience Feedback Form weekly via REDCap to assess&#xD;
      feasibility and acceptability of Endeavor™. At the conclusion of participation, participants&#xD;
      will complete an hour long neuropsychological evaluation and end of study User Experience&#xD;
      Feedback Form via REDCap (in-person at the MSCCC, or through a telehealth video visit).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Insufficient funds and limited staffing to complete the pilot program.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2023</start_date>
  <completion_date type="Actual">February 23, 2023</completion_date>
  <primary_completion_date type="Actual">February 23, 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent compliance for total at-home sessions</measure>
    <time_frame>End of study (Day 60)</time_frame>
    <description>Participants will be categorized as &quot;compliant&quot; if they interact with the mobile Endeavor™ a minimum of 3 times per week for a minimum of six of the eight weeks across the study period of 60 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fatigue in Adult participants</measure>
    <time_frame>Baseline (Day 0), End of study (Day 60)</time_frame>
    <description>The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue form will be completed by the adult MS patients (7 questions). The PROMIS Fatigue instrument evaluate a range of self-reported symptoms that likely decrease the subjects' ability to carry out daily activities and might have an influence on cognitive function and processing speed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fatigue in Pediatric participants</measure>
    <time_frame>Baseline (Day 0), End of study (Day 60)</time_frame>
    <description>The PROMIS Pediatric Fatigue form (23 questions) will be completed by the pediatric MS subjects enrolled in this study. The PROMIS Fatigue instrument evaluate a range of self-reported symptoms that likely decrease the subjects' ability to carry out daily activities and might have an influence on cognitive function and processing speed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression in Participants</measure>
    <time_frame>Baseline (Day 0), End of study (Day 60)</time_frame>
    <description>The PROMIS Depression form (28 questions) and PROMIS Pediatric Depression form (13 questions) evaluates self-reported negative mood symptoms and social cognition. This assessment will be completed for the adult MS patients (PROMIS Depression) and the pediatric MS subjects (PROMIS Pediatric Depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life in Participants</measure>
    <time_frame>Baseline (Day 0), End of study (Day 60)</time_frame>
    <description>The MS Quality of Life Inventory (MSQoL) 54 Instrument is a health-related quality of life measure that combines both generic and MS-specific items and will be completed by the adult MS patients enrolled in this study. The instrument consists of 54 self-report items and yields two summaries, a health composite summary and a mental health composite summary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in behaviors in pediatric participants.</measure>
    <time_frame>Baseline (Day 0), End of study (Day 60)</time_frame>
    <description>To determine and control for depressive and other behavioral symptoms on cognitive functioning, the Behavioral Assessment Scale for Children Third Edition (BASC-III) will be administered to pediatric MS subjects in this study. The assessments describe specific behaviors that are rated on a four-point scale of frequency, ranging from Never to Almost Always and include statements such as &quot;My parents listen to what I say&quot; and &quot;I like to take risks.&quot; This 189-item assessment will help in determining behavioral patterns. These rating scales are performed on a computer.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Endeavor™ Action Video Game Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 participants will fill out questionnaires and complete a neuropsychological evaluation. During study participation, participants will target using Endeavor™ action video game to complete 25-30 minutes at-home sessions 5 days a week for a total of 8 weeks via an iOS application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Action Video Game Treatment</intervention_name>
    <description>Endeavor™ is a digital, non-drug investigational treatment that is delivered through an action video game and is designed to target cognitive deficits in adolescence and young adults with pediatric onset MS.</description>
    <arm_group_label>Endeavor™ Action Video Game Treatment</arm_group_label>
    <other_name>Endeavor™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age at enrollment: 12 years 0 months to 22 years 11 months&#xD;
&#xD;
          -  Confirmed Diagnosis of Multiple Sclerosis with onset &lt; 17 years and 11 months (defined&#xD;
             by the 2013 International Pediatric MS Study Group (IPMSSG) criteria (Krupp, Tardieu,&#xD;
             Amato, Banwell, Chitnis, Dale, Ghezzi, Hintzen, Kornberg, Pohl, Rostasy, Tenembaum,&#xD;
             Wassmer, &amp; Sclerosis, 2013) and the 2010 McDonald criteria (Polman et al., 2011).)&#xD;
&#xD;
          -  Followed at NYU Langone Health MSCCC&#xD;
&#xD;
          -  Expanded Disability Status Scale (EDSS) score of ≤3.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous report of an IQ &lt; 70&#xD;
&#xD;
          -  Non-English speaking, learned English in the past three years, or learned English&#xD;
             after the age of 12 years&#xD;
&#xD;
          -  Neurological disorder (other than MS) with potential to significantly influence&#xD;
             cognition (e.g. head injury)&#xD;
&#xD;
          -  Other serious chronic or unstable medical condition (e.g., epilepsy, sickle cell&#xD;
             disease, Type 1 diabetes)&#xD;
&#xD;
          -  Not willing to comply with all study procedures&#xD;
&#xD;
          -  Insufficient visual and motor ability to carry out academic and cognitive tests&#xD;
&#xD;
          -  Relapse ≤ 2months prior to academic and cognitive data collection&#xD;
&#xD;
          -  Steroid treatment ≤ 1 month prior to academic and cognitive data collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leigh Charvet, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health - Ambulatory Care Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research</ipd_time_frame>
    <ipd_access_criteria>The investigator who proposed to use the data.Upon reasonable request. equests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT04445116
org study id: 20-00634
nct id: NCT04445116
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study will examine the feasibility of using an Endeavor™ application as a treatment
      modality for cognitive impairments in the pediatric MS population. Participants will be asked
      to undergo a hour-long baseline evaluation, followed by at-home Endeavor™ application
      sessions. Subjects will complete the User Experience Feedback Form weekly on REDCap and at
      the end of the study. They will undergo another hour-long follow-up evaluation at the end of
      the study.
Duration of subject participation in this study is anticipated to take 3-4 months. After
      consent/assent, participants will complete an one hour-long baseline study visit in-person at
      the MSCCC, or through a video visit. During this visit, participants will complete a
      neuropsychological evaluation and baseline study surveys and get trained on the use of the
      Endeavor™ video game. Participants will then be instructed to target a completion of at-home
      game play 5 days a week, for a total period of 8 weeks, using their own iOS mobile device, or
      a study-provided device if needed, approximately 25-30 minutes each day. Subjects will be
      instructed to complete the User Experience Feedback Form weekly via REDCap to assess
      feasibility and acceptability of Endeavor™. At the conclusion of participation, participants
      will complete an hour long neuropsychological evaluation and end of study User Experience
      Feedback Form via REDCap (in-person at the MSCCC, or through a telehealth video visit).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent compliance for total at-home sessions
time frame: End of study (Day 60)
description: Participants will be categorized as "compliant" if they interact with the mobile Endeavor™ a minimum of 3 times per week for a minimum of six of the eight weeks across the study period of 60 days.
measure: Change in Fatigue in Adult participants
time frame: Baseline (Day 0), End of study (Day 60)
description: The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue form will be completed by the adult MS patients (7 questions). The PROMIS Fatigue instrument evaluate a range of self-reported symptoms that likely decrease the subjects' ability to carry out daily activities and might have an influence on cognitive function and processing speed.
measure: Change in Fatigue in Pediatric participants
time frame: Baseline (Day 0), End of study (Day 60)
description: The PROMIS Pediatric Fatigue form (23 questions) will be completed by the pediatric MS subjects enrolled in this study. The PROMIS Fatigue instrument evaluate a range of self-reported symptoms that likely decrease the subjects' ability to carry out daily activities and might have an influence on cognitive function and processing speed.
measure: Change in Depression in Participants
time frame: Baseline (Day 0), End of study (Day 60)
description: The PROMIS Depression form (28 questions) and PROMIS Pediatric Depression form (13 questions) evaluates self-reported negative mood symptoms and social cognition. This assessment will be completed for the adult MS patients (PROMIS Depression) and the pediatric MS subjects (PROMIS Pediatric Depression).
measure: Change in Quality of life in Participants
time frame: Baseline (Day 0), End of study (Day 60)
description: The MS Quality of Life Inventory (MSQoL) 54 Instrument is a health-related quality of life measure that combines both generic and MS-specific items and will be completed by the adult MS patients enrolled in this study. The instrument consists of 54 self-report items and yields two summaries, a health composite summary and a mental health composite summary.
measure: Change in behaviors in pediatric participants.
time frame: Baseline (Day 0), End of study (Day 60)
description: To determine and control for depressive and other behavioral symptoms on cognitive functioning, the Behavioral Assessment Scale for Children Third Edition (BASC-III) will be administered to pediatric MS subjects in this study. The assessments describe specific behaviors that are rated on a four-point scale of frequency, ranging from Never to Almost Always and include statements such as "My parents listen to what I say" and "I like to take risks." This 189-item assessment will help in determining behavioral patterns. These rating scales are performed on a computer.
arm group label: Endeavor™ Action Video Game Treatment
arm group type: Experimental
description: 25 participants will fill out questionnaires and complete a neuropsychological evaluation. During study participation, participants will target using Endeavor™ action video game to complete 25-30 minutes at-home sessions 5 days a week for a total of 8 weeks via an iOS application.
intervention type: Device
intervention name: Action Video Game Treatment
description: Endeavor™ is a digital, non-drug investigational treatment that is delivered through an action video game and is designed to target cognitive deficits in adolescence and young adults with pediatric onset MS.
arm group label: Endeavor™ Action Video Game Treatment
other name: Endeavor™
criteria: 
gender: All
minimum age: 12 Years
maximum age: 22 Years
healthy volunteers: No
last name: Leigh Charvet, PhD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
ipd access criteria: The investigator who proposed to use the data.Upon reasonable request. equests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.