Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Developmental Assessment of Young Children-2nd edition (DAYC-2) Standard Scores of the Communication Domain as a Measure of Direct Comparison of the 2 Testing Conditions.
研究概览
简要总结
To compare in-person to remote video assessments in children to determine the reliability of remote evaluations for future neuropsychological assessments and set a precedent for future investigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents able to provide informed consent for themselves and their child
- •Access to computer and reliable internet connection for remote testing
- •Child of women with epilepsy who was taking antiseizure medications during the pregnancy of the child being enrolled into the current study
- •Child between the ages of 24 months and 30 months of age
- •Primary language is English
排除标准
- •Child unable to complete the cognitive assessment (e.g., expected IQ<70)
- •Child with a major medical condition (e.g., epilepsy, diabetes, heart disease, active cancer)
- •Child who use centrally active medications
结局指标
主要结局
Developmental Assessment of Young Children-2nd edition (DAYC-2) Standard Scores of the Communication Domain as a Measure of Direct Comparison of the 2 Testing Conditions.
时间窗: Change from the first, baseline assessment to the second assessment, 21 days later.
Standardized Scores of DAYC-2 Communication Domain at end of each period for each intervention (i.e., in-person testing and remote testing). The standard score indicates the deviation away from a reference population. A standard score of 100 is equal to the mean. Numbers less than 100 indicate poor cognitive performance compared to the mean and numbers greater than 100 represent higher cognitive performance compared to the mean.
次要结局
未报告次要终点
研究者
Kimford Jay Meador
Professor of Neurology
Stanford University