Endeavor™ in Pediatric MS

Multiple Sclerosis Clinical Trial

— Akili  

Official title:

A Study of Endeavor™, a Video-Game Based Cognitive Remediation, in the Pediatric Multiple Sclerosis (MS) Population

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04445116
• Other study ID #: 20-00634
• Status: Withdrawn
• Phase: N/A
• Start date: January 2023
• Est. completion date: February 23, 2023

Study information

• Verified date: May 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Action Video Game Treatment
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.

Locations

Country	Name	City	State
United States	NYU Langone Health - Ambulatory Care Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	End of study (Day 60)
Secondary	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.	Baseline (Day 0), End of study (Day 60)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)