Speech Entrainment for Aphasia Recovery (SpARc)

失语症恢复的言语诱导 (SpARc)

• 批准号: 10005301
• 负责人: Leonardo F Bonilha
• 金额: $ 84.71万
• 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/10005301
• 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.

抽象的 尽管最近在急性中风治疗方面取得了进步，但有20％的慢性中风幸存者患有 持久的语言障碍（失语症）。非浮力失语症是失语症的最常见形式之一， 它与社会隔离直接相关，参与康复疗法和低点 生活质量。精通语音的重新建立是治疗过程中最具挑战性的方面之一 患有慢性非素质失语症的受试者。作为这个问题的新颖替代方法，我们的小组优化了 新的和有前途的治疗方法标题为“语音夹带疗法”（SET），主题的语音 在笔记本计算机上呈现的视听模型（由）沿着（指导）沿着（指导）。在初步和证明 概念研究，我们观察到，非浮力失语症的受试者可以克服流利性的障碍 并用set产生更多流利的语音。他们每分钟的动词提高了20％ （VPM）在治疗后三个月的自发演讲中。这些是非常令人鼓舞的发现 因为它们代表了在话语期间产生动词的持续后处理后的收益，所以这是有效的 与产生名词或命名相比，生态措施和语言能力的更好预测指标 对象。在这些发现的激励中，我们提出了一个前瞻性受控的随机评估阶段 ii临床试验，标题为“失语症恢复（SPARC）的语音夹带”，以更好地评估语言 与集合相关的改进，并确定集合的最佳剂量。该试验将是多站点（5 网站）项目，将注册150个持续稳定的中风幸存者，患有非浮力失语，主要是主要的 结果后3个月将是VPM。我们将使用无缝的两阶段选择设​​计， 其中将包括第1阶段以选择最佳的固定剂量和一个阶段2来评估集合的全部效果。在 第1阶段，患者将被随机分为3种不同剂量的集合：每天3或4.5或6周，设置1小时， 或对照（无治疗）条件（4组中的每例患者有20例）。基于预定义的规则，我们 将选择证明足够耐受性的剂量，并且是最高的组平均值 治疗后3个月的VPM。在第2阶段，我们将招募70名患者，并随机分配1：1 到选定的设置持续时间或对照组。最终分析将测试是否从 使用入学的患者，选定的设定持续时间组的VPM基线比对照组更好 如果阶段1和2。设置将被认为值得进一步研究，如果它导致20％或以上的改善 与NO治疗对照条件相比，治疗后3个月的VPM。这项研究将提供 更好地了解集合的治疗益处，确定其最佳剂量并确定其影响是否 将证明对这种新的和有希望的治疗形式的未来研究是合理的。