Protocol for Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR): A randomized, double-blind, sham-controlled trial.
Protocol for Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR): A randomized, double-blind, sham-controlled trial.
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小脑刺激失语症康复方案 (CeSAR)：一项随机、双盲、假对照试验。
DOI：
10.1101/2024.02.05.24302365
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发表时间：
2024
期刊：
影响因子：
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通讯作者：
Sebastian,Rajani
中科院分区：
文献类型：
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作者：
Lammers,Becky;Sydnor,MyraJ;Cust,Sarah;Kim,JiHyun;Yenokyan,Gayane;Hillis,ArgyeE;Sebastian,Rajani
在这项随机、双盲、假对照的小脑刺激失语症康复（塞萨尔）试验中，我们将确定右侧小脑阴极tDCS（经颅直流电刺激）治疗慢性失语症（卒中后>6个月）的有效性。我们将检验以下假设：与假手术加SFA相比，小脑tDCS联合循证命名障碍治疗（语义特征分析，SFA）与治疗后1周未训练图片命名的更大改善（通过费城图片命名测试的变化测量）相关。我们还将评估小脑tDCS对命名训练项目的影响，以及对功能性沟通、内容、效率和图片描述的词检索以及生活质量的影响。最后，我们将确定影像学和语言学生物标志物，以确定受益于小脑tDCS和SFA治疗的卒中患者的特征。我们希望在五年内招募60名参与者。受试者将接受15、25分钟的小脑tDCS治疗（每周3-5次）或假tDCS联合1小时的SFA治疗。将在治疗开始前、治疗后1周、治疗后1个月、3个月和6个月对受试者进行主要和次要结局变量评价。本研究的长期目的是为一项III期随机对照试验提供基础，该试验比较小脑tDCS与假手术，同时进行语言治疗以治疗慢性失语症。试验注册：该试验在ClinicalTrials.gov NCT 05093673注册。
In this randomized, double-blind, sham-controlled trial of Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR), we will determine the effectiveness of cathodal tDCS (transcranial direct current stimulation) to the right cerebellum for the treatment of chronic aphasia (>6 months post stroke). We will test the hypothesis that cerebellar tDCS in combination with an evidenced-based anomia treatment (semantic feature analysis, SFA) will be associated with greater improvement in naming untrained pictures (as measured by the change in Philadelphia Picture Naming Test), 1-week post-treatment, compared to sham plus SFA. We will also evaluate the effects of cerebellar tDCS on naming trained items as well as the effects on functional communication, content, efficiency, and word-retrieval of picture description, and quality of life. Finally, we will identify imaging and linguistic biomarkers to determine the characteristics of stroke patients that benefit from cerebellar tDCS and SFA treatment. We expect to enroll 60 participants over five years. Participants will receive 15, 25-minute sessions of cerebellar tDCS (3–5 sessions per week) or sham tDCS combined with 1 hour of SFA treatment. Participants will be evaluated prior to the start of treatment, one-week post-treatment, 1-, 3-, and 6-months post-treatment on primary and secondary outcome variables. The long-term aim of this study is to provide the basis for a Phase III randomized controlled trial of cerebellar tDCS vs sham with concurrent language therapy for treatment of chronic aphasia.Trial registration:The trial is registered with ClinicalTrials.gov NCT05093673.