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Endeavor™ in Pediatric MS (Akili)

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ClinicalTrials.gov Identifier: NCT04445116
Recruitment Status : Not yet recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Endeavor™ Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Endeavor™, a Video-Game Based Cognitive Remediation, in the Pediatric Multiple Sclerosis (MS) Population
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endeavor group
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.
Other: Endeavor™
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. Endeavor™ is an investigational product, meaning that it is currently being tested and is not yet cleared by the U.S. Food and Drug Administration (FDA).




Primary Outcome Measures :
  1. Percent compliance for total at-home sessions [ Time Frame: End of study (Day 60) ]
    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.


Secondary Outcome Measures :
  1. Change in Fatigue in Adult participants [ Time Frame: Baseline (Day 0), End of study (Day 60) ]
    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.

  2. Change in Fatigue in Pediatric participants [ Time Frame: Baseline (Day 0), End of study (Day 60) ]
    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.

  3. Change in Depression in Participants [ Time Frame: Baseline (Day 0), End of study (Day 60) ]
    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).

  4. Change in Quality of life in Participants [ Time Frame: Baseline (Day 0), End of study (Day 60) ]
    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.

  5. Change in behaviors in pediatric participants. [ Time Frame: Baseline (Day 0), End of study (Day 60) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at enrollment: 12 years 0 months to 22 years 11 months
  • Confirmed Diagnosis of Multiple Sclerosis with onset < 17 years and 11 months (defined by the 2013 International Pediatric MS Study Group (IPMSSG) criteria (Krupp, Tardieu, Amato, Banwell, Chitnis, Dale, Ghezzi, Hintzen, Kornberg, Pohl, Rostasy, Tenembaum, Wassmer, & Sclerosis, 2013) and the 2010 McDonald criteria (Polman et al., 2011).)
  • Followed at NYU Langone Health MSCCC
  • Expanded Disability Status Scale (EDSS) score of ≤3.5

Exclusion Criteria:

  • Previous report of an IQ < 70
  • Non-English speaking, learned English in the past three years, or learned English after the age of 12 years
  • Neurological disorder (other than MS) with potential to significantly influence cognition (e.g. head injury)
  • Other serious chronic or unstable medical condition (e.g., epilepsy, sickle cell disease, Type 1 diabetes)
  • Not willing to comply with all study procedures
  • Insufficient visual and motor ability to carry out academic and cognitive tests
  • Relapse ≤ 2months prior to academic and cognitive data collection
  • Steroid treatment ≤ 1 month prior to academic and cognitive data collection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445116


Contacts
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Contact: Leigh Charvet, PhD 929-455-5141 Leigh.Charvet@nyulangone.org

Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Leigh Charvet, PhD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04445116    
Other Study ID Numbers: 20-00634
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases