Clinical trial NCT04445116: Endeavor™ in Pediatric MS
Official title: A Study of Endeavor™, a Video-Game Based Cognitive Remediation, in the Pediatric Multiple Sclerosis (MS) Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: Percent compliance for total at-home sessions
timeFrame: End of study (Day 60)
Secondary outcomes:
measure: Change in Fatigue in Adult participants
timeFrame: Baseline (Day 0), End of study (Day 60)
measure: Change in Fatigue in Pediatric participants
timeFrame: Baseline (Day 0), End of study (Day 60)
measure: Change in Depression in Participants
timeFrame: Baseline (Day 0), End of study (Day 60)
measure: Change in Quality of life in Participants
timeFrame: Baseline (Day 0), End of study (Day 60)
measure: Change in behaviors in pediatric participants.
timeFrame: Baseline (Day 0), End of study (Day 60)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health - Ambulatory Care Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet, PhD
role: PRINCIPAL_INVESTIGATOR
References: