Speech Entrainment for Aphasia Recovery (SpARc)

失语症恢复的言语诱导 (SpARc)

基本信息

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
项目类别：
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

项目摘要

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.

抽象的尽管急性中风的治疗最近取得了进展，但 20% 的慢性中风幸存者患有以下疾病：长期的语言障碍（失语症）。不流利失语症是最常见的失语症形式之一，它与社会孤立、康复治疗参与减少以及低水平直接相关生活质量。重建流利的言语是治疗过程中最具挑战性的方面之一患有慢性非流利性失语症的受试者。作为这个问题的新颖替代方案，我们的团队优化了名为言语夹带疗法（SET）的新的有前途的治疗方法，其中受试者的言语是沿着笔记本电脑上呈现的视听模型拉动（引导）的。在初步和证明概念研究中，我们观察到患有非流利性失语症的受试者可以克服流利性障碍并使用 SET 产生更流利的语音。他们每分钟的动词数量提高了 20% 以上 (VPM) 治疗后三个月的自发言语期间。这些都是非常令人鼓舞的发现因为它们代表了在话语过程中产生动词的持续治疗后收益，这是一个有效的生态测量，与产生名词或命名相比，可以更好地预测语言能力对象。受这些发现的启发，我们提出了一个前瞻性对照随机评估者盲法阶段题为“失语症恢复言语诱导”（SpARc）的 II 期临床试验，以更好地评估语言能力与 SET 相关的改善，并确定 SET 的最佳剂量。该试验将是多地点的（5 站点）项目将招募 150 名患有不流利失语症的长期稳定中风幸存者，以及主要结果将是治疗后 3 个月时的 VPM。我们将使用无缝两阶段剂量选择设计，其中包括选择最佳 SET 剂量的第一阶段和评估 SET 全部效果的第二阶段。在第 1 阶段，患者将被随机接受 3 种不同剂量的 SET：3、4.5 或 6 周每天 1 小时的 SET，或对照（无治疗）条件（4 组中每组 20 名患者）。根据预先定义的规则，我们将选择表现出足够耐受性并与最高组平均水平相关的剂量治疗后 3 个月的 VPM。在第二阶段，我们将另外招募 70 名患者，并以 1:1 的比例随机分配他们到选定的 SET 持续时间或对照组。最终分析将测试是否改变所选 SET 持续时间组的 VPM 基线优于使用入组患者的对照组第 1 阶段和第 2 阶段。如果 SET 能带来 20% 或更多的改善，则 SET 将被认为值得进一步研究。治疗后 3 个月的 VPM 与未治疗对照条件进行比较。这项研究将提供更好地了解 SET 的治疗益处，确定其最佳剂量，并确定其效果是否将证明这种新的、有前途的治疗形式的未来研究是合理的。