Endeavor™ in Pediatric MS (Akili)

NYU Langone Health

Status: Withdrawn

Conditions: Multiple Sclerosis

Treatments: Device: Action Video Game Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04445116

20-00634

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 12 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Endeavor™ Action Video Game Treatment

Experimental group

Description:

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.

Treatment:

Device: Action Video Game Treatment