Cassarly Christy, Doyle Anna, Ly Trinh, Horn Janet, Aitchison Mary, Elm Jordan, Fridriksson Julius, Bonilha Leonardo
Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Department of Neurology, Medical University of South Carolina, Charleston, SC, USA.
Contemp Clin Trials Commun. 2021 Nov 16;24:100876. doi: 10.1016/j.conctc.2021.100876. eCollection 2021 Dec.
and purpose: Speech entrainment therapy (SET) is a computerized therapeutic approach that involves mimicking an audiovisual speech model to improve speech production. In a pilot study using SET for treatment of post-stroke non-fluent aphasia, significant gains were achieved in verbs per minute (VPM) during discourse using untrained items 1 and 6 weeks after treatment, suggesting that SET may yield meaningful improvements in fluent spontaneous speech for individuals with non-fluent aphasia
The Speech Entrainment for Aphasia Recovery (SpARc) trial is a prospective, randomized, assessor-blinded, multicenter phase II clinical trial studying persons with chronic post-stroke non-fluent aphasia. Participants will be randomized to 3 weeks, 4.5 weeks, or 6 weeks of SET delivered via telehealth or a no SET control condition for 6 weeks. 80 adults (ages 21-81) with history of left hemisphere ischemic or hemorrhagic stroke with residual chronic (>6 months post stroke) non-fluent aphasia diagnosed by the Western Aphasia Battery-Revised (WAB-R) will be randomized (1:1:1:1) over 4 years. The trial will be conducted at the clinical research facilities at three sites: the Medical University of South Carolina, the University of South Carolina, and the University of Utah.
This paper details the trial design of the SpARc trial, which aims to determine the dose of SET that will generate the highest effect size on speech fluency, VPM, sustained at 3 months post-treatment compared to a no SET control arm, for individuals with chronic post-stroke non-fluent aphasia to permit a future definitive trial to test the clinical utility of SET.
言语同步疗法（SET）是一种计算机化治疗方法，通过模仿视听言语模型来改善言语表达。在一项使用SET治疗中风后非流畅性失语症的初步研究中，治疗后1周和6周使用未经训练的项目进行话语交流时，每分钟动词数量（VPM）有显著增加，这表明SET可能会使非流畅性失语症患者的流畅自发言语有显著改善。
失语症恢复言语同步（SpARc）试验是一项前瞻性、随机、评估者盲法、多中心II期临床试验，研究慢性中风后非流畅性失语症患者。参与者将被随机分为接受通过远程医疗提供的3周、4.5周或6周的SET治疗组，或接受为期6周的无SET对照组。80名年龄在21 - 81岁之间、有左半球缺血性或出血性中风病史且经西方失语症成套测验修订版（WAB-R）诊断为残留慢性（中风后>6个月）非流畅性失语症的成年人将在4年内随机分组（1:1:1:1）。该试验将在三个地点的临床研究机构进行：南卡罗来纳医科大学、南卡罗来纳大学和犹他大学。
本文详细介绍了SpARc试验的试验设计，该试验旨在确定与无SET对照组相比，哪种SET剂量能在治疗后3个月对慢性中风后非流畅性失语症患者的言语流畅性、VPM产生最大效应量，并能持续保持，以便未来进行确定性试验来测试SET的临床效用。
