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Insufficient funds and limited staffing to complete the pilot program.
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This study will examine the feasibility of using an Endeavorâ„¢ 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 Endeavorâ„¢ 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 Endeavorâ„¢ 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 Endeavorâ„¢. 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endeavorâ„¢ Action Video Game Treatment | Experimental | 25 participants will fill out questionnaires and complete a neuropsychological evaluation. During study participation, participants will target using Endeavorâ„¢ 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Action Video Game Treatment | Device | Endeavorâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent compliance for total at-home sessions | Participants will be categorized as "compliant" if they interact with the mobile Endeavorâ„¢ a minimum of 3 times per week for a minimum of six of the eight weeks across the study period of 60 days. | End of study (Day 60) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Charvet, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health - Ambulatory Care Center | New York | New York | 10017 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
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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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
| 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. | 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). | 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. | 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. | Baseline (Day 0), End of study (Day 60) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |