Endeavor™ in Pediatric MS

NCT04445116 | Withdrawn DMC FDA Device

• 1 other identifier: 20-00634
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Fatigue in Adult participants

  Baseline (Day 0), End of study (Day 60)

• Change in Fatigue in Pediatric participants

  Baseline (Day 0), End of study (Day 60)

• Change in Depression in Participants

  Baseline (Day 0), End of study (Day 60)

• Change in Quality of life in Participants

  Baseline (Day 0), End of study (Day 60)

• Change in behaviors in pediatric participants.

  Baseline (Day 0), End of study (Day 60)

Study Arms (1)

Endeavor™ Action Video Game Treatment

EXPERIMENTAL

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.

Device: Action Video Game Treatment

Interventions

Action Video Game Treatment DEVICE

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.

Also known as: Endeavor™

Endeavor™ Action Video Game Treatment

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health - Ambulatory Care Center

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Leigh Charvet, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: January 1, 2023
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. equests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)