A Study of Endeavor™, a Video-Game Based Cognitive Remediation, in the Pediatric Multiple Sclerosis (MS) Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percent compliance for total at-home sessions
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percent compliance for total at-home sessions
时间窗: End of study (Day 60)
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.
次要结局
- 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 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))
- Change in Depression in Participants(Baseline (Day 0), End of study (Day 60))