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: 10094380
• 负责人: Argye E. Hillis
• 金额: $ 42.13万
• 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/10094380
• 关键词: Affect; Aftercare; Alleles; Amphetamines; Anodes; Anxiety; Aphasia; Brain; Brain-Derived Neurotrophic Factor; Clinical Trials; Communication; Computers; Data; Dopamine; Double-Blind Method; Education; Effectiveness; Electronic Mail; Escitalopram; FDA approved; Fluoxetine; Functional Magnetic Resonance Imaging; Genes; Genetic Polymorphism; Genotype; Goals; Hospitals; Hour; Individual; Infarction; Insurance; Interpersonal Relations; Intervention; Language; Language Therapy; Left; Lesion; Light; Literature; Magnetic Resonance Imaging; Measures; Mediating; Medical; Mental Depression; Motor; Names; Outcome; Participant; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Placebos; Production; Provider; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; 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; base; cognitive recovery; design; disability; double-blind placebo controlled trial; genetic testing; improved; language impairment; meetings; motor recovery; neuromechanism; post stroke; response; secondary outcome; side effect; social; stroke survivor; stroke-induced aphasia; 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.

项目总结(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， 因为它会干扰个人的社交互动、重返工作的能力，甚至是简单的日常生活 活动，如回复电子邮件或接听电话。言语和语言治疗(SLT)可以是 有助于恢复语言功能，但恢复往往是不完全的。最近的研究表明，马达和 卒中后的认知恢复可以用选择性5-羟色胺再摄取抑制剂(SSRIs)来增强。使用 这项建议，我们的目的是评估卒中后3个月每天给予SSRI，爱司匹兰，对 加强语言恢复。我们将比较艾司西普兰加SLT和安慰剂加SLT在 双盲随机对照试验(RCT)。SLT将包括两人的标准语言治疗 几个月后，每天在电脑上进行命名治疗(对照组)，从两点开始，持续15个疗程 月份。我们选择这项SLT是为了使我们能够比较艾司匹兰和经颅的疗效。 在我们正在进行的tdcs合并失语症的研究中，直流电刺激(Tdcs)与具有相同SLT的假刺激(Sham)的比较 亚急性卒中的治疗。我们将评估艾司替普兰对未训练对象命名的效果(其中之一 失语症中最常见的缺陷)，其次，它对形态合成的产生、内容和 叙述性语言的效率、生活质量和残疾。我们将评估治疗和治疗的影响 人口统计变量、病变体积、白质疾病、失语症和中风严重程度，以及关于以下方面的教育 结果。根据失语症康复研究中心最近的研究和文献， 我们还将确定可能通过治疗来调节语言恢复效果的神经机制， 包括脑源性神经营养因子(BDNF)基因异常多态性的影响。我们 我还将评估埃西妥普兰在静息状态下(或激活时的相关性)对功能连通性的影响 在大脑中“语言网络”的区域与大脑中的其他网络之间，如运动 网络)，比较任何干预前后的静息状态功能连通性MRI 服用SLT的安慰剂。这一目标可能有助于阐明艾司西妥兰如何影响语言和/或 独立于依西他普兰对抑郁症的影响，在药物治疗或不治疗的情况下，语言能力如何恢复。 我们将在一项名为Escitalopram的随机对照试验中检验我们的假设，该试验用于亚急性失语症的语言改善(ELISA)。 失语症参与者和研究人员在研究结束前都不会被揭发。长的- 本研究的长期目标是为艾司西普兰的III期随机对照试验提供基础， ANODAL-TDC或两者联合SLT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(S)可能会增强SLT，并使我们能够选择最好的候选人进行治疗 更大规模的研究。