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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
NYU Langone Health - Ambulatory Care Center
New York, New York, United States
Percent compliance for total at-home sessions
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.
Time frame: End of study (Day 60)
Change in Fatigue in Adult participants
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.
Time frame: Baseline (Day 0), End of study (Day 60)
Change in Fatigue in Pediatric participants
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.
Time frame: Baseline (Day 0), End of study (Day 60)
Change in Depression in Participants
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).
Time frame: Baseline (Day 0), End of study (Day 60)
Change in Quality of life in Participants
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline (Day 0), End of study (Day 60)
Change in behaviors in pediatric participants.
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.
Time frame: Baseline (Day 0), End of study (Day 60)