Endeavor™ in Pediatric MS

A Study of Endeavor™, a Video-Game Based Cognitive Remediation, in the Pediatric Multiple Sclerosis (MS) Population

WithdrawnNot a drug-phase studyMS (type not specified)NCT04445116

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: Insufficient funds and limited staffing to complete the pilot program.

What was tested

Treatment tested

  • Action Video Game Treatment

What it measured

Main measures

  • Percent compliance for total at-home sessions

    End of study (Day 60)

Other measures (5)

  • Change in Fatigue in Adult participants

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

    Thinking and memoryFatigueQuality of life (reported by participants)

  • Change in Fatigue in Pediatric participants

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

    Thinking and memoryFatigue

  • Change in Depression in Participants

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

    Thinking and memoryMood and sleep

  • Change in Quality of life in Participants

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

    Quality of life (reported by participants)

  • Change in behaviors in pediatric participants.

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

    Thinking and memoryMood and sleep

Who could take part

MS (type not specified) · 12 to 22

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jan 2023

      2. Main results due

        Feb 2023

      3. Finished

        Feb 2023

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