Escitalopram and Language Intervention for Subacute Aphasia (ELISA)

艾司西酞普兰和亚急性失语症语言干预 (ELISA)

• 批准号: 10617711
• 负责人: Argye E. Hillis
• 金额: $ 45.02万
• 依托单位: UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10617711
• 关键词: Affect; Aftercare; Alleles; Amphetamines; Anodes; Anxiety; Aphasia; Brain; Brain-Derived Neurotrophic Factor; Clinical Trials; Communication; Computers; Data; Dextroamphetamine; Dopamine; Double-Blind Method; Education; Effectiveness; Electronic Mail; Escitalopram; FDA approved; Fluoxetine; Functional Magnetic Resonance Imaging; Genes; Genetic Carriers; Genetic Polymorphism; Genotype; Goals; Hospitals; Hour; Individual; Infarction; Insurance; Interpersonal Relations; Intervention; Language; Language Therapy; Left; Lesion; Literature; Magnetic Resonance Imaging; Measures; Mediating; Medical; Mental Depression; Motor; Names; Outcome; Participant; Persons; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Placebos; Production; Provider; Quality of life; Randomized; Randomized, Controlled Trials; Recovery; Recovery Support; Rehabilitation therapy; Research; Research Personnel; Residual state; Rest; Risk; Selective Serotonin Reuptake Inhibitor; Severities; Single Nucleotide Polymorphism; Social Interaction; Speech; Stroke; Structure; Superior temporal gyrus; Survivors; Telephone; Testing; Transcranial magnetic stimulation; United States; White Matter Disease; Work; aphasia recovery; cognitive recovery; design; disability; double-blind placebo controlled trial; genetic testing; improved; language impairment; meetings; motor recovery; neuromechanism; post stroke; randomized placebo-controlled clinical trial; response; secondary outcome; side effect; social; stroke survivor; stroke-induced aphasia; transcranial direct current stimulation; treatment response

Project Summary (Project 2) Aphasia, or language impairment, is among the most devastating problems after left hemisphere stroke, because it can interfere with an individual’s social interactions, ability to return to work, and even simple daily activities, such as returning email or answering the phone. Speech and language treatment (SLT) can be helpful in restoring language function, but recovery is often incomplete. Recent studies indicate that motor and cognitive recovery after stroke can be augmented with selective serotonin reuptake inhibitors (SSRIs). With this proposal, we aim to evaluate the effect of an SSRI, escitalopram, given daily for 3 months after stroke, on augmenting language recovery. We will compare the effects of escitalopram plus SLT to placebo plus SLT in a double blind, randomized controlled trial (RCT). SLT will consist of “standard” language therapy for two months, followed by a daily, computer-delivered naming therapy (CoDeNT) over 15 sessions beginning at two months. We selected this SLT to enable us to compare the effects of escitalopram to the effect of transcranial direct current stimulation (tDCS) versus sham with the same SLT, in our ongoing study of tDCS plus aphasia treatment in subacute stroke. We will evaluate the effect of escitalopram on naming untrained objects (one of the most common deficits in aphasia), and secondarily, its effects on morphosyntactic production, content and efficiency of narrative speech, quality of life, and disability. We will evaluate the influence of treatment and demographic variables, lesion volume, white matter disease, aphasia and stroke severity, and education on outcome. Based on recent studies from the Center for the Study of Aphasia Recovery and from the literature, we will also identify neural mechanisms that may mediate the effects of language recovery with treatment, including the influence of abnormal polymorphisms in the brain derived neurotrophic factor (BDNF) gene. We will also evaluate the effects of escitalopram on “functional connectivity” at rest (or correlations in activation between regions of “the language network” in the brain versus other networks in the brain, such as the motor network), comparing resting state functional connectivity MRI before any intervention and after escitalopram or placebo with SLT. This aim may shed light on the mechanisms of how escitalopram affects language, and/or how language recovers with or without medication, independently on the effects of escitalopram on depression. We will test our hypotheses in a RCT, Escitalopram for Language Improvement in Subacute Aphasia (ELISA). Neither the participant with aphasia nor the investigator will be unmasked until the end of the study. The long- term aim of this study is to provide the basis for a Phase III randomized controlled trial of either escitalopram, anodal-tDCS, or both with concurrent SLT for treatment of subacute aphasia. This study will help us determine which intervention(s) is likely to augment SLT and allow us to select the best candidates for treatment in the larger study.

项目摘要（项目2） 失语症或语言障碍是左半球中风后最具破坏性的问题之一 因为它可以干扰个人的社交互动，重返工作的能力，甚至每天简单 活动，例如返回电子邮件或接听电话。语音和语言处理（SLT）可以是 有助于恢复语言功能，但恢复通常是不完整的。最近的研究表明运动和 可以通过选择性5-羟色胺再摄取抑制剂（SSRIS）来增强中风后的认知恢复。和 该提议，我们旨在评估SSRI，依然瓜的效果，每天在中风后三个月给予，对 增强语言恢复。我们将比较Escitalopram加上SLT的影响与安慰剂加上SLT 双盲，随机对照试验（RCT）。 SLT将包括两个的“标准”语言疗法 几个月，随后是每天进行的每日计算机命名疗法（代码），超过15个课程。 月份。我们选择了此SLT，以使我们能够比较依源妥妥丙酰胺的影响与经颅的影响 在我们正在进行的TDC和失语症的研究中 亚急性中风的治疗。我们将评估依他普兰对命名未经训练的物体的影响（之一 失语症和次要的最常见缺陷对形态同步生产，内容和 叙事言论，生活质量和残疾的效率。我们将评估治疗的影响和 人口统计学变量，病变量，白质疾病，失语症和中风严重程度以及教育 结果。根据来自失语症恢复研究中心的最新研究以及文献的研究 我们还将确定可以通过治疗介导语言恢复效果的神经机制， 包括异常多态性在脑衍生的神经营养因子（BDNF）基因中的影响。 还将评估依他普兰在休息时对“功能连接”的影响（或激活的相关性 在大脑中“语言网络”与大脑中的其他网络（例如电动机）之间 网络），比较静止状态功能连通性MRI在任何干预之前和依源瓜之后或之后 安慰剂与SLT。这个目标可能会阐明依源妥拉姆如何影响语言的机制和/或 语言如何在有或没有药物治疗的情况下恢复，独立于依源妥拉兰对抑郁症的影响。 我们将在RCT，依他张兰州中测试我们的假设，以改善亚急性失语症（ELISA）的语言。 在研究结束之前，失语症和研究者的参与者都不会被揭露。长期 这项研究的术语目的是为Eccitalopram的III期随机对照试验提供基础， 阳极-TDC，或同时使用的SLT，用于治疗亚急性失语症。这项研究将帮助我们确定 哪种干预措施可能会增加SLT，并允许我们选择最好的治疗候选者 更大的研究。