Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- BrainHQ Learning Rate
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 10 - 16 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 tDCS in children and adolescents with PAE. Functional magnetic resonance imaging will be collected to provide preliminary data of brain circuitry changes created by this intervention. The study involves a baseline visit with cognitive testing, MRI, 5 sessions of tDCS (including the baseline visit), and a 6th visit for cognitive testing and MRI. All sessions will be completed within a 28 to 56 day time window.
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
- 10 Years 至 16 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
BrainHQ Learning Rate
时间窗: Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.
Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance
次要结局
- Change in D-KEFS Verbal Fluency - Category(D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline))
- Delis Rating of Executive Functioning (D-REF)(D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that baseline scores are listed previously in the appropriate section)
- Change in D-KEFS Trail-making - Numbers(D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline))
- Change in Flanker Inhibitory Control and Attention Task(NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline))
- Change in D-KEFS Trail-making - Letters(D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline))
- Change in D-KEFS Trail-making - Combined(D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline))
- Change in D-KEFS Verbal Fluency - Letter(D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline))