Status:
WITHDRAWN
Endeavor™ in Pediatric MS
Lead Sponsor:
NYU Langone Health
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
12-22 years
Phase:
NA
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...
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 thr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04445116
Start Date
January 1 2023
End Date
February 23 2023
Last Update
May 6 2023
Active Locations (1)
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1
NYU Langone Health - Ambulatory Care Center
New York, New York, United States, 10017