tDCS and cognitive training as a neurodevelopmental intervention in FASD

经颅直流电刺激 (tDCS) 和认知训练作为 FASD 的神经发育干预

基本信息

批准号：
10467243
负责人：
JEFFREY ROBERT WOZNIAK
金额：
$ 44.43万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-10 至 2027-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10467243
关键词：
Adolescent Age Attention Attention deficit hyperactivity disorder Behavior Behavioral Brain Child Client Clinical Clinical Trials Cognition Cognitive deficits Craniofacial Abnormalities Data Development Dose Fetal Alcohol Exposure Fetal Alcohol Spectrum Disorder Fetal alcohol effects Functional Magnetic Resonance Imaging Future Growth Hour Impaired cognition Impairment Independent Living Individual Intervention Intervention Studies Investments Lead Left Life Link Measures Mediating Mental Health Methodology Neurocognitive Neurologic Neuronal Plasticity Outcome Outcome Measure Parents Participant Performance Pilot Projects Placebos Population Prefrontal Cortex Public Health Publishing Randomized Controlled Trials Regimen Reporting Research Rest Short-Term Memory Social Functioning Symptoms Testing Therapeutic Time Training arm behavioral impairment clinical implementation cognitive control cognitive function cognitive performance cognitive training comparison intervention computerized design dosage emotional functioning executive function improved learned behavior neuroregulation performance tests post intervention relating to nervous system response safety and feasibility social skills sustained attention treatment effect voltage

项目摘要

PROJECT SUMMARY / ABSTRACT Fetal alcohol spectrum disorders (FASDs) comprise a range of effects from prenatal alcohol exposure (PAE) including neurological abnormalities, cognitive and behavioral impairments, growth retardation, and craniofacial anomalies. Very few treatments have been investigated despite the tremendous public health burden posed by FASD. Cognition is a natural target for intervention because deficits contribute to problems with adaptive functioning, social skills, and independent living. A decade of research suggests that cognitive training has beneficial effects on functional brain networks - mediating cognition in a variety of neurodevelopmental and mental health conditions. We believe it can improve cognitive performance in individuals with FASD. The primary objective of our existing line of neuromodulation research and the proposed RCT is to leverage the ability of tDCS to enhance cortical excitability and neural plasticity in order to maximize the cognitive training benefits in children and adolescents with FASD. Recently we carried out a pilot randomized controlled trial of tDCS-augmented cognitive training to demonstrate the safety and feasibility of this approach in children with FASD (Boroda, Krueger, et al., 2020). We showed that the intervention was safe and well-tolerated in this population. Further, despite applying a relatively low-dose of tDCS and cognitive training, we found that the group receiving active-tDCS demonstrated greater improvements on an attention task than a group receiving sham-tDCS. These promising pilot results merit replication in a larger clinical trial. We propose a fully-powered randomized controlled trial of 60 (at completion) children and adolescents with FASD who will receive cognitive training in combination with tDCS. We hypothesize that, in conjunction with cognitive training, five initial sessions of active tDCS will produce a significantly greater improvement in sustained attention (CPT) than sham tDCS. We also hypothesize that, in conjunction with cognitive training, a total of ten sessions of active tDCS will produce a significantly greater improvement in sustained attention (CPT) than five sessions of active tDCS. We also aim to establish the long-term durability of neurocognitive improvements and associated behavioral changes resulting from tDCS and cognitive training. Finally, we plan to use pre-intervention and post-intervention resting-state fMRI data to show functional network changes related to the intervention and to quantify the relationship between dose and functional network changes. Results of the trial will directly inform future clinical implementation of cognitive training and tDCS as a potential neurodevelopmental intervention.

项目概要/摘要胎儿酒精谱系障碍 (FASD) 包括产前酒精暴露带来的一系列影响 (PAE) 包括神经系统异常、认知和行为障碍、生长迟缓、和颅面异常。尽管有巨大的进展，但对治疗方法的研究却很少 FASD 造成的公共卫生负担。认知是干预的自然目标，因为缺陷导致适应性功能、社交技能和独立生活方面的问题。十年来研究表明认知训练对功能性大脑网络有有益的影响 - 调节各种神经发育和心理健康状况的认知。我们相信可以改善 FASD 患者的认知能力。我们现有的主要目标神经调节研究的路线和拟议的 RCT 是利用 tDCS 的能力来增强皮质兴奋性和神经可塑性，以最大限度地提高儿童的认知训练效益以及患有 FASD 的青少年。最近，我们进行了一项 tDCS 增强认知的随机对照试验培训以证明这种方法对 FASD 儿童的安全性和可行性（Boroda，克鲁格等人，2020）。我们表明，该干预措施在该人群中是安全且耐受性良好的。此外，尽管应用了相对低剂量的 tDCS 和认知训练，我们发现该组接受主动 tDCS 后，在注意力任务上的改善比一组有更大的改善接受假-tDCS。这些有希望的试点结果值得在更大规模的临床试验中复制。我们建议对 60 名（完成时）儿童进行全功效随机对照试验，患有 FASD 的青少年将接受与 tDCS 相结合的认知训练。我们假设与认知训练相结合，主动 tDCS 的五次初始课程将产生与假 tDCS 相比，持续注意力 (CPT) 的改善显着更大。我们也假设与认知训练相结合，总共十次主动 tDCS 将与五次主动训练相比，持续注意力 (CPT) 的改善明显更大经颅直流电刺激。我们还旨在建立神经认知改善的长期持久性 tDCS 和认知训练引起的相关行为变化。最后，我们计划使用干预前和干预后静息态功能磁共振成像数据显示功能网络变化与干预相关并量化剂量和功能网络之间的关系变化。试验结果将直接为未来认知训练的临床实施提供信息 tDCS 作为一种潜在的神经发育干预措施。