tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Continuous Performance Test performance
研究概览
简要总结
This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 8 - 17 years) with prenatal alcohol exposure (PAE).
详细描述
Prenatal alcohol exposure (PAE) has profound detrimental effects on brain development and, as a result, has permanent consequences for cognition, learning, and behavior. Individuals with Fetal Alcohol Spectrum Disorders (FASD) commonly have a range of neurocognitive impairments that directly lead to practical problems with learning, attention, working memory, task planning/execution, and decision making, among other areas of functioning. Despite the profound public health burden posed by FASD, there have been very few treatment studies in this population. This study will examine the effects of a cognitive remediation training augmented with transcranial direct current stimulation (tDCS) in children and adolescents with PAE. The study involves a baseline visit with cognitive testing, 5 sessions of tDCS (including the baseline visit) with active and sham arms, a 6th visit for cognitive testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants and families will be blinded. The principal investigator will be blinded. The research staff member coordinating the visit will be blinded. The care provider is not involved in the research and is, therefore, blinded.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented heavy prenatal alcohol exposure (self-report, social service records, or adoption records) and meeting criteria for an associated FASD diagnosis (FAS, partial FAS, or ARND).
- •An available parent or legal guardian capable of giving informed consent
排除标准
- •Substance abuse in the participant
- •Neurological condition or other developmental disorder
- •Serious psychiatric disorder known to affect brain functioning and cognitive performance Birthweight < 1500 grams
- •MRI contraindication
- •tDCS contraindication
结局指标
主要结局
Change in Continuous Performance Test performance
时间窗: After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)
Change in Continuous Performance Test performance
Change in Delis-Kaplan Executive Function System Color Word Interference performance
时间窗: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Delis-Kaplan Executive Function System - Color Word Interference performance
Change in Wechsler Digit Span performance
时间窗: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance
Change in Wechsler Picture Span performance
时间窗: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance
Change in Delis-Kaplan Executive Function System -Trail Making performance
时间窗: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Delis-Kaplan Executive Function System - Trail Making performance
次要结局
- Change in Oral Word Reading Fluency performance(Visit 1 and Visit 5 (approx. 3 weeks apart))
- Change in Math Fluency performance(Visit 1 and Visit 5 (approx. 3 weeks apart))