Department of Communication Sciences & Disorders, University of South Carolina, Columbia.
Department of Psychology, University of South Carolina, Columbia.
JAMA Neurol. 2018 Dec 1;75(12):1470-1476. doi: 10.1001/jamaneurol.2018.2287.
Aphasia is a debilitating language disorder for which behavioral speech therapy is the most efficient treatment, but therapy outcomes are variable and full recovery is not always achieved. It remains unclear if adjunctive brain stimulation (anodal transcranial direct current stimulation [A-tDCS]) applied during aphasia therapy can improve outcomes.
To examine the futility of studying A-tDCS as an adjunctive intervention during speech therapy to improve speech production (naming) for individuals with long-term poststroke aphasia.
DESIGN, SETTING, AND PARTICIPANTS: Double-blinded, prospective randomized clinical trial using a futility design to test adjunctive A-tDCS during speech therapy. The setting was an outpatient clinic. Enrollment of individuals began in August 2012 and was completed in March 2017, and the duration of follow-up was 6 months. Analyses began in April 2017. The study recruited from a volunteer sample, and 89 patients were screened. Patients with long-term (>6 months) aphasia due to 1 previous left hemisphere stroke were enrolled. In comparing A-tDCS and sham tDCS, patients were matched based on site (University of South Carolina or Medical University of South Carolina), baseline age, type of aphasia, and aphasia severity.
Outpatient speech therapy for 3 weeks (15 sessions, 45 minutes each) combined with either A-tDCS vs sham tDCS applied to preserved left temporal lobe regions.
The primary outcome was the ability to name common objects, assessed twice before and after therapy.
A total of 74 patients were enrolled. Participants had a mean (SD) age of 60 (10) years, had 15 (2) years of education, and were 44 (40) months from stroke onset. There were 52 men (70%) and 62 non-Hispanic white individuals (84%). Most were retired or not employed (59 [80%]). Broca aphasia was the most common aphasia type (39 [52.7%]). The adjusted mean (SE) change from pretreatment baseline in correct naming was 13.9 (2.4) words (95% CI, 9.0-18.7) for A-tDCS and 8.2 (2.2) words (95% CI, 3.8-12.6) for sham tDCS, with mean (SE) A-tDCS difference of 5.7 (3.3) words (95% CI, -0.9 to 12.3), indicating a relative 70% increase in correct naming for A-tDCS relative to sham. The futility hypothesis P value was .90, indicating failure to reject the null hypothesis and, therefore, providing no evidence that further study of A-tDCS is futile. No serious adverse events were associated with A-tDCS.
Our findings provide motivation to proceed with another trial to study the effect of A-tDCS on the outcome of aphasia treatment in individuals poststroke. Anodal tDCS during speech therapy is feasible and potentially transformative for aphasia treatment and should be further studied.
ClinicalTrials.gov Identifier: NCT01686373.
失语症是一种使人衰弱的语言障碍，行为言语疗法是最有效的治疗方法，但治疗效果因人而异，并非总能完全康复。目前尚不清楚在失语症治疗过程中辅助使用脑刺激（经颅直流电刺激[anodal transcranial direct current stimulation，A-tDCS]）是否可以改善治疗效果。
检验在言语治疗中辅助使用 A-tDCS 对改善长期卒中后失语症患者的言语生成（命名）是否无效果。
设计、设置和参与者：采用双盲、前瞻性随机临床试验设计和无效性设计，以检验言语治疗中辅助使用 A-tDCS 的效果。研究地点为门诊。2012 年 8 月开始入组患者，2017 年 3 月完成入组，随访时间为 6 个月。分析于 2017 年 4 月开始。本研究从志愿者样本中招募患者，共筛选了 89 例患者。纳入的患者均为左半球卒中后 6 个月以上的长期失语症患者。在比较 A-tDCS 和假刺激 tDCS 时，基于病灶部位（南卡罗来纳大学或南卡罗来纳医科大学）、基线年龄、失语症类型和失语症严重程度对患者进行匹配。
3 周的门诊言语治疗（15 次治疗，每次 45 分钟），联合使用 A-tDCS 或 sham tDCS 刺激左侧颞叶保留区。
主要结局为治疗前后两次评估的常见物体命名能力。
共纳入 74 例患者。患者的平均（SD）年龄为 60（10）岁，接受过 15（2）年的教育，距卒中发病时间为 44（40）个月。男性 52 例（70%），非西班牙裔白人 62 例（84%）。多数为退休或无业（59 [80%]）。最常见的失语症类型为 Broca 失语症（39 [52.7%]）。治疗前基线时正确命名的平均（SE）变化值为 A-tDCS 组 13.9（2.4）个词（95%CI，9.0-18.7），sham tDCS 组 8.2（2.2）个词（95%CI，3.8-12.6），A-tDCS 组平均（SE）差值为 5.7（3.3）个词（95%CI，-0.9 至 12.3），表明 A-tDCS 组正确命名的相对增加率为 70%。无效性假设 P 值为.90，表明未拒绝无效假设，因此，没有证据表明进一步研究 A-tDCS 是无效的。A-tDCS 未引起严重不良事件。
我们的发现为在另一个临床试验中研究 A-tDCS 对卒中后失语症患者治疗结局的影响提供了动力。在言语治疗期间使用 A-tDCS 是可行的，并且可能对失语症治疗具有变革性，应该进一步研究。
ClinicalTrials.gov 标识符：NCT01686373。
