Multiple Sclerosis Clinical Trial
Endeavorâ„¢ in Pediatric MS
Summary
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.
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 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).
Eligibility Criteria
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
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There is 1 Location for this study
New York New York, 10017, United States
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