Speech Entrainment for Aphasia Recovery (SpARc)

失语症恢复的言语诱导 (SpARc)

• 批准号: 10241330
• 负责人: Leonardo F Bonilha
• 金额: $ 84.62万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10241330
• 关键词: Affect; Aftercare; Aphasia; Blinded; Brain; Broca Aphasia; Chronic; Clinical; Cognitive; Comprehension; Computers; Control Groups; Controlled Study; Data; Dose; Enrollment; Future; Global Aphasia; Hour; Impairment; Individual; Language; Linguistics; Measures; Modeling; Names; Neurologic; Patients; Persons; Phase II Clinical Trials; Pilot Projects; Production; Quality of life; Randomized; Rehabilitation therapy; Sampling; Site; Social isolation; Specific qualifier value; Speech; Speech Therapy; Stroke; Testing; Therapeutic; Uncontrolled Study; Visual; Visual system structure; acute stroke; aphasia recovery; base; chronic stroke; design; experience; innovation; language impairment; laptop; novel; novel strategies; optimal treatments; post stroke; preservation; primary endpoint; primary outcome; prospective; standard of care; stroke survivor; therapy duration; tool; treatment comparison; treatment duration

Abstract In spite of recent advances in the treatment of acute stroke, 20% of chronic stroke survivors suffer from long-lasting language impairments (aphasia). Non-fluent aphasia is one of the most common forms of aphasia, and it is directly associated with social isolation, decreased participation in rehabilitation therapies, and low quality of life. The reestablishment of fluent speech is one of the most challenging aspects during the treatment of subjects with chronic non-fluent aphasia. As a novel alternative to this problem, our group has optimized a new and promising treatment approach entitled speech entrainment therapy (SET), where the subject's speech is pulled along (guided by) an audio-visual model presented on a laptop computer. In a preliminary and proof of concept study, we observed that subjects with non-fluent aphasia could overcome the barrier towards fluency and produce more fluent speech with SET. They had greater than 20% improvement in verbs per minute (VPM) during spontaneous speech at three months after therapy. These are very encouraging findings because they represent sustained post-treatment gains in producing verbs during discourse, which is a valid ecological measure, and a better predictor of language abilities compared with producing nouns or naming objects. Motivated by these findings, we propose a prospective controlled randomized assessor blinded phase II clinical trial entitled Speech entrainment for Aphasia Recovery (SpARc) to better assess the linguistic improvements associated with SET, and to determine the optimal dose of SET. This trial will be a multisite (5 sites) project that will enroll 150 chronically stable stroke survivors with non-fluent aphasia, and the primary outcome will be VPM at 3 months post-therapy. We will use a Seamless Two-Stage Dose Selection design, which will include a Stage 1 to choose the best SET dose, and a Stage 2 to assess the full effects of SET. In Stage 1, the patients will be randomized to 3 different doses of SET: 3 or 4.5 or 6 weeks of 1 hour daily SET, or a control (no treatment) condition (20 patients in each one of the 4 groups). Based on a pre-defined rule, we will select the dose that demonstrated adequate tolerability and was associated the highest group average VPM at 3 months post treatment. In Stage 2, we will enroll 70 additional patients and randomly assign them 1:1 to either the selected SET duration or the control group. The final analysis will test whether the change from baseline in VPM for the selected SET duration group is better than the control group using patients enrolled in Stages 1 and 2. SET will be considered worthy of further study if it leads to an improvement in 20% or more in VPM at 3 months after therapy compared with the no treatment control condition. This study will provide a better understanding of the therapeutic benefits of SET, determine its best dose, and decide whether its effects would justify future studies of this new and promising form of therapy.

摘要 尽管最近在治疗急性中风方面取得了进展，但20%的慢性中风幸存者患有 长期的语言障碍(失语症)。不流利的失语症是失语症最常见的形式之一， 它直接与社会孤立、参与康复治疗的减少和低 生活质量。重建流利的语言是治疗过程中最具挑战性的方面之一 慢性非流利失语症的受试者。作为这个问题的一种新的替代方案，我们的团队优化了一个 名为言语夹带疗法(SET)的新的有希望的治疗方法，其中受试者的言语 在笔记本电脑上呈现的视听模型的引导下进行。在初步的和证明的 概念研究，我们观察到非流利失语症的受试者可以克服通向流利的障碍 并使用SET产生更流畅的语音。他们每分钟的动词数提高了20%以上 (VPM)在治疗后三个月的自发言语中。这些都是非常令人鼓舞的发现 因为它们代表了在语篇中产生动词的持续的后处理收益，这是一个有效的 生态指标，与产生名词或命名相比，是更好的语言能力预测指标 物体。基于这些发现，我们提出了一个前瞻性随机评估盲化阶段。 II名为言语夹带失语症康复(SPARC)的临床试验，以更好地评估语言 与SET相关的改进，并确定SET的最佳剂量。这项试验将是一项多点试验(5 网站)项目，将招募150名患有非流利性失语的长期稳定的中风幸存者，以及初级 治疗后3个月的结果将是VPM。我们将使用无缝两阶段剂量选择设计， 这将包括选择最佳SET剂量的阶段1和评估SET的全部效果的阶段2。在……里面 第一阶段，患者随机接受3种不同剂量的SET：3周、4.5周或6周，每天1小时， 或对照组(未治疗)(4组各20例)。基于预定义的规则，我们 将选择显示出足够耐受性并与组内平均值最高相关的剂量 治疗后3个月的VPM。在第二阶段，我们将再招募70名患者，并随机分配1：1 设置为选定的持续时间或控制组。归根结底，将测试是否从 所选设置持续时间组的VPM基线比使用患者登记的对照组更好 阶段1和阶段2。如果SET在以下方面有20%或更多的改善，则认为值得进一步研究 治疗后3个月VPM与未治疗对照组比较。这项研究将提供一个 更好地了解SET的治疗益处，确定其最佳剂量，并决定其效果 将证明未来对这种新的和有前途的治疗形式的研究是合理的。