Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
- 试验地点
- 38
- 主要终点
- Change in communication ability, as assessed by the Amsterdam Nijmegen Everyday Language Test
研究概览
简要总结
The aim of the study is to investigate whether intensive speech-language therapy (SLT) combined with anodal transcranial direct current stimulation (tDCS) leads to better communication performance than SLT combined with placebo stimulation (using sham-tDCS).
详细描述
Intensive speech-language therapy (SLT) can promote recovery from chronic post-stroke aphasia, but effect sizes are moderate. This highlights the pressing need to explore adjunct strategies, such as transcranial direct current stimulation (tDCS), to enhance training effectiveness. Recently, the investigators provided evidence from a single-center randomized controlled trial (RCT) suggesting that anodal-tDCS of the left primary motor cortex (M1) improves naming and communication ability in chronic post-stroke aphasia, with medium-to-large effect sizes. However, prior to integration into clinical routine, a multi-center RCT with adequate power, duration, and outcomes relevant to everyday life is required, which is the goal of the present study. After trial completion, a workshop with relevant stakeholders will ensure transfer into best-practice guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •left-hemisphere cortical or subcortical stroke with first-ever aphasic symptoms
- •at least 6 months post-onset of stroke;
- •aphasia, as determined by the Aachen Aphasia Test (AAT);
- •13 moderate-to-severe word finding difficulties (maximum of 75% correct items on a computerized naming task at baseline);
- •at least 1 correct reaction on the first part of the AAT subscale Token Test (ensuring basic comprehension skills);
- •at least 1 point on the communicative task of the AAT subscale Spontaneous Speech (ensuring basic communication abilities);
- •German as first language;
- •intact left-hemisphere "hand knob" without right prefrontal lesions for placement of tDCS electrodes, as confirmed by magnetic resonance imaging or computer tomography scans.
排除标准
- •contraindications for tDCS (e.g., cardiac pacemaker, history of seizures, implanted metal inside the head);
- •more than one clinically apparent stroke with aphasic symptoms;
- •other severe neurological diseases (e.g., brain tumor, and subdural hematoma);
- •epilepsy with seizures during the last 12 months prior to study start and/or intake of sedating antiepileptic drugs (barbiturates and benzodiazepines),
- •history of severe alcohol or drug abuse;
- •current severe depression;
- •current psychosis or other relevant psychiatric condition;
- •very severe apraxia of speech, as revealed by Hierarchical Word Lists;
- •severe non-verbal cognitive deficits, as indicated by the Corsi Block-Tapping Task;
- •severe uncontrolled medical problems;
- •severely impaired vision or hearing that prevents patients from engaging in intensive SLT;
- •changes in centrally active drugs within 2 weeks prior to study inclusion.
结局指标
主要结局
Change in communication ability, as assessed by the Amsterdam Nijmegen Everyday Language Test
时间窗: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Amsterdam Nijmegen Everyday Language Test (A-scale; parallel versions used in counterbalanced order across participants); cf. Blomert L, Kean ML, Koster C, et al. Amsterdam-Nijmegen Everyday Language Test-Construction, Reliability and Validity. Aphasiology 1994; 8: 381-407.
次要结局
- Change in (non-)verbal communication, as assessed by the Scenario Test(Before the 3-week treatment period; 6-month follow-up)
- Change in attention and executive function, as assessed by the subscales Go/NoGo and Alertness from Test of Attentional Performance(Before the 3-week treatment period; 6-month follow up)
- Change in health-related quality of life, as assessed by the EuroQol Health-Related Quality of Life Questionnaire(Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups)
- Change in direct and indirect costs during the 12-month study period, as assessed by the Quality-Adjusted Life Years(Before the 3-week treatment period; 6- and 12-month follow ups)
- Change in mood, as assessed by the German version of the 10-item Stroke Aphasic Depression Questionnaire(Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups)
- Change in direct and indirect costs during the 12-month study period, as assessed by the self-developed Patient Resource Consumption Questionnaire(Before the 3-week treatment period; 6- and 12-month follow ups)
- Change in unpaid support provided by family members or friends, as assessed by the Burden of informal caregivers(Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups)
- Change in naming ability, as assessed based on personally relevant trained and untrained items, consistent with previous work (see description)(Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups)
- Change in (non-)verbal communication, as assessed by the Communicative Effectiveness Index(Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups)
- Change in non-verbal episodic memory, as assessed by the Figure Recognition Task from Benton Visual Retention Test(Before the 3-week treatment period; 6-month follow up)
- Change in health-related quality of life, as assessed by the Stroke and Aphasia Quality of Life Scale(Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups)