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
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Endeavor™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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).
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
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
|Contact: Leigh Charvet, PhD||929-455-5141||Leigh.Charvet@nyulangone.org|
|Principal Investigator:||Leigh Charvet, PhD||NYU Langone Health|