TDCS-enhanced training in chronic post-stroke aphasia
TDCS-enhanced training in chronic post-stroke aphasia
批准号:
371431740
负责人:
Professorin Dr. Agnes Flöel
金额:
$0.0万
依托单位:
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
项目状态:
已结题
起止时间:
2018-12-31 至 2023-12-31
中文摘要
强化SLT可以促进慢性中风后失语的恢复,失语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。这一发现强调需要新的策略,尤其是tDCS,这是一种易于实施、耐受性良好且成本低的方法。最近,一项单中心随机对照试验表明,对左初级运动皮层和右前额叶皮层进行强化SLT联合阳极tDCS,可以改善慢性中风后失语症的功能和活动相关结果,具有中大型效应。为了在临床实践中进一步证实这些发现,现在需要一项具有足够功效、治疗持续时间和相关结果的多中心随机对照试验。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SLT联合tDCS对脑卒中后慢性失语症患者沟通能力的影响(样本量:130例患者;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,推进医疗保健系统并降低社会成本。试验完成后,我们将与相关利益攸关方组织研讨会,确保将其转化为最佳实践指南。
英文摘要
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.
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