tDCS Augmentation of Cognitive Remediation in Schizophrenia

tDCS 增强精神分裂症认知修复

• 批准号: 8717732
• 负责人: DANIEL C. JAVITT
• 金额: $ 25.21万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-08 至 2015-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8717732
• 关键词: Achievement; Acoustic Stimulation; Auditory; Auditory Perception; Auditory area; Auditory system; Behavior Therapy; Behavioral; Biological Assay; Brain; Brain region; Brain-Derived Neurotrophic Factor; Chronic Schizophrenia; Clinical Research; Clinical Trials; Cognition; Cognitive remediation; Detection; Devices; Disease; Dose; Double-Blind Method; EP300 gene; Effectiveness; Electrodes; Emotions; Event-Related Potentials; Exercise; Frequencies; Functional disorder; Future; Generations; Glutamates; Goals; Impaired cognition; Impairment; Individual; Intervention; Investigation; Lead; Learning; Measures; Mediating; Mediator of activation protein; Modality; Monitor; Motor; Neurocognition; Neurocognitive; Neurocognitive Deficit; Neuronal Plasticity; Occupational; Outcome; Patients; Phase; Pilot Projects; Plasma; Procedures; Process; Protocols documentation; Randomized; Reading; Recovery; Relative (related person); Safety; Schizophrenia; Sensory; Serine; Short-Term Memory; Social Functioning; Tinnitus; Training; Treatment Efficacy; Verbal Learning; base; behavior measurement; cognitive function; design; functional outcomes; improved; indexing; innovation; neurochemistry; neurophysiology; novel; psychosocial; public health relevance; remediation; response; social; social cognition; statistics; stroke rehabilitation; theories; visual motor

DESCRIPTION (provided by applicant): This project evaluates the efficacy of combined transcranial direct current stimulation (tDCS) and auditory neuroplasticity based remediation in Schizophrenia (Sz). Auditory dysfunction is a core feature of Sz and contributes to impairments in emotion recognition, verbal working memory, reading and social cognition. Prior studies of auditory remediation have demonstrated improvements in cognition, in combination with indices of improved neuroplasticity. tDCS is a newly developed brain stimulation modality that enhances local neuroplasticity across brain regions. To date it has been used primarily for stroke rehabilitation. This will be the first study of efficacy for augmentation of cognitive remediation n Sz. We have recently demonstrated that tDCS significantly enhances concomitant event-related potential (ERP) generation when applied during learning situations, permitting direct assay of target engagement. For the present study, ERP will be used to monitor target engagement and treatment efficacy. The project is responsive to the RFA (PAR 11-177) in the following ways: 1) This represents a biologically informed, novel and highly innovative approach to alter a functional treatment target (auditory dysfunction) which is relevant to functional outcome in Sz; 2) brain stimulation (tDCS) will be conducted using an IDE-approved device in combination with a previously validated behavioral intervention; and 3) proof-of-principle for the combination approach is required prior to initiation of an RCT. Assessments will assess impact of the intervention at multiple levels (behavioral, neurochemical, neurophysiological). The R21 phase is necessary to pilot the interventions. The R33 phase is designed to pilot the interventions and demonstrate feasibility of recruitment, retention, assessment procedures and safety, and to obtain an initial assessment of effect-size for use in planning a future, definitive trial. No inferential statistics are proposed. Although the present study focuses on persistent auditory deficits in chronic Sz patients, investigation of tDCS efficacy in enhancement of neuroplasticity will be relevant across a range of disorders and neurocognitive constructs.

描述（由申请人提供）：该项目评估联合经颅直流电刺激（tDCS）和基于听觉神经可塑性的治疗对精神分裂症（Sz）的疗效。听觉功能障碍是 Sz 的核心特征，会导致情绪识别、言语工作记忆、阅读和社会认知障碍。先前的听觉矫正研究已经证明认知能力得到改善，同时神经可塑性指标也得到改善。 tDCS 是一种新开发的大脑刺激方式，可增强大脑区域的局部神经可塑性。迄今为止，它主要用于中风康复。这将是第一个关于增强认知矫正功效的研究。我们最近证明，在学习情况下应用 tD​​CS 可以显着增强伴随事件相关电位 (ERP) 的生成，从而可以直接测定目标参与度。对于本研究，ERP 将用于监测目标参与度和治疗效果。该项目通过以下方式响应 RFA (PAR 11-177)： 1) 这代表了一种基于生物学的、新颖且高度创新的方法，用于改变与 Sz 功能结果相关的功能治疗目标（听觉功能障碍）； 2) 将使用 IDE 批准的设备并结合先前验证的行为干预进行脑刺激 (tDCS)； 3) 在启动 RCT 之前需要对组合方法进行原理验证。评估将评估干预措施在多个层面（行为、神经化学、神经生理学）的影响。 R21 阶段对于试点干预措施是必要的。 R33阶段旨在试点干预措施并证明招募、保留、评估程序和安全性的可行性，并获得效果大小的初步评估以用于规划未来的最终试验。没有提出推论统计。尽管目前的研究重点是慢性 Sz 患者的持续性听觉缺陷，但对 tDCS 在增强神经可塑性方面的功效的研究将与一系列疾病和神经认知结构相关。