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.

强化SLT可以促进中风后慢性失语的恢复，这是中风最具破坏性的后果之一。然而，效应大小适中(约10%)，可能反映了训练引起的功能变化的潜在生理极限。这一发现强调了新战略的必要性，最明显的是tdcs，一种易于实施、容忍度良好和低成本的方法。最近，一项单中心随机对照试验表明，强化SLT联合阳极tDCs应用于左侧初级运动和右侧前额叶皮质，可以改善慢性卒中后失语患者的功能和活动相关结果，效果为中到大。为了在临床实践中进一步确定这些发现，现在需要一个具有足够的功率、治疗持续时间和相关结果的多中心随机对照试验。本研究采用双盲、假刺激控制、平行分组的随机对照试验，旨在探讨强化SLT联合TDCs对慢性卒中后失语患者沟通能力的影响(样本量：130例，卒中后6个月以上，13个参与中心)。次要终点包括评估生活质量、不良事件和干预成本效益的措施。积极的结果将有利于患者及其家人的生活质量，促进医疗体系的发展，降低社会成本。在试验完成后，我们将与相关利益攸关方组织一次研讨会，以确保将其转化为最佳做法准则。