TDCS-enhanced training in chronic post-stroke aphasia

TDCS 强化训练治疗慢性卒中后失语症

• 批准号: 371431740
• 负责人: Professorin Dr. Agnes Flöel
• 金额: --
• 依托单位: Hochschule Fresenius
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2019
• 资助国家: 德国
• 起止时间: 2018-12-31 至 2023-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/371431740?language=en
• 关键词: TDCS; enhanced; training; chronic; post

Intensive SLT can promote recovery from chronic post-stroke aphasia, one of the most devastating consequences of stroke. However, effect sizes are moderate (around 10%), likely reflecting a potential physiological limit of training-induced functional changes. This finding emphasizes the need for new strategies, most notably tDCS, an easy-to-implement, well-tolerated and low-cost approach. Recently, a single-center RCT has demonstrated that intensive SLT combined with anodal tDCS applied to the left primary motor and right prefrontal cortex improves both function- and activity-related outcomes in chronic post-stroke aphasia, with medium-to-large effect sizes. A multi-center RCT with sufficient power, treatment duration, and relevant outcomes is now required to further establish these findings in clinical practice. The primary aim of the present double-blind, sham stimulation-controlled, parallel-group RCT is to determine the effect of intensive SLT combined with tDCS on communication abilities in chronic post-stroke aphasia (sample size: 130 patients; more than 6 months post-onset of stroke; 13 participating centers). Secondary endpoints include measures evaluating quality of life, adverse events and cost-effectiveness of the intervention. Positive results will benefit the quality of life for patients and their families, advance the healthcare system and reduce societal costs. Upon trial completion, we will organize a workshop with relevant stakeholders to ensure transfer into best-practice guidelines.

密集的失语症可以促进中风后慢性失语症的恢复，这是中风最具破坏性的后果之一。然而，效应大小是中等的（约10%），可能反映了训练引起的功能变化的潜在生理限制。这一发现强调了新战略的必要性，特别是tDCS，这是一种易于实施、耐受性良好和成本低的方法。最近，一项单中心随机对照试验表明，在慢性卒中后失语症患者中，应用于左侧初级运动和右侧前额叶皮质的强化tDCS联合阳极tDCS可改善功能和活动相关结局，具有中等至大的效应量。现在需要一项具有足够把握度、治疗持续时间和相关结局的多中心随机对照试验，以在临床实践中进一步确定这些结果。本双盲、假刺激对照、平行组随机对照试验的主要目的是确定强化多巴胺联合tDCS对慢性卒中后失语症患者沟通能力的影响（样本量：130例患者;卒中发作后6个月以上; 13个参与中心）。次要终点包括评估生活质量、不良事件和干预的成本效益的措施。积极的结果将有利于患者及其家属的生活质量，促进医疗保健系统的发展，并降低社会成本。在试验完成后，我们将与相关利益相关者组织一次研讨会，以确保将其转化为最佳实践指南。