Non-invasive brain stimulation for swallowing recovery after a dysphagic stroke

描述(申请人提供)：项目摘要：吞咽障碍是中风的一种常见和严重的并发症，但缺乏有效的治疗方法。在此，我们建议进行一项前瞻性的临床研究，使用无创脑刺激技术--阳极经颅直流电刺激(TDC)，结合吞咽训练改善急性-亚急性半球梗塞所致的吞咽困难，并获得2种不同剂量的TDC对吞咽生理和行为的安全性和疗效的数据。半球卒中的吞咽困难是由于大脑干吞咽中枢的皮质投射中断所致，而吞咽功能的恢复被证明是通过未受影响的大脑半球吞咽皮质的重组而调节的。我们最近的初步研究表明，在急性-亚急性卒中阶段，对健侧大脑半球的吞咽皮质进行连续5次每天30分钟的阳极tdcs治疗是安全可行的，并显示出结合吞咽练习改善吞咽困难的前景。这项拟议的研究将被用来进一步证实这项技术在中风早期阶段的安全性，并在任何验证性试验检查之前，探索促进吞咽恢复的替代、更有效的剂量。我们将使用我们的研究队列来检查重要的特定对象参数，这些参数影响我们建议的对吞咽困难卒中患者的干预反应。这项研究的总体目标是收集卒中急性期-亚急性期TDC累积疗程的额外安全数据，获得有关这种干预对重要生理和临床相关吞咽参数的影响的信息，检查可能的剂量效应，并确定更有可能从这种干预中受益的候选者。从这个项目中获得的经验将指导未来的验证性试验的规划，这些试验使用相关的临床结果来评估这种干预的潜在好处，并利用重要的受试者特定参数来改进研究纳入标准，并帮助进行严重程度调整的分析。

DESCRIPTION (provided by applicant): Project Summary: Swallowing impairments are a common and a serious complication of stroke but lack effective therapies. We herein propose to conduct a prospective clinical study using a non-invasive brain stimulation technique, anodal transcranial direct current stimulation (tDCS), in combination with swallowing exercises for improving dysphagia due to an acute-subacute hemispheric infarction, and obtain data on safety and effect of 2 different doses of tDCS, on swallowing physiology and behavior. Dysphagia from hemispheric strokes occurs due to disruption of the cortical projections to the brainstem swallowing centers while recovery of swallowing functions have been shown to be mediated via the reorganization of the swallowing cortex in the unaffected hemisphere. Our recent pilot study demonstrates that application of 5 consecutive daily sessions of anodal tDCS for 30 minutes to the swallowing cortex on the unaffected hemisphere is safe and feasible in the acute-subacute stroke phases and shows a promise in improving dysphagia, when combined concomitantly with swallowing exercises. The proposed research will be used to further confirm safety of this technique in early stroke phases and explore alternative, more effective doses for promoting swallowing recovery prior to its examination in any confirmatory trials. We will use our study cohort to examine important subject-specific parameters which influence response to our proposed intervention in dysphagic stroke patients. The overall aim of this study is to gather additional safety data on cumulative sessions of tDCS in acute-subacute phases of stroke, obtain information about effects of this intervention on important physiological and clinically relevant swallowing parameters, examine possible dose effects, and identify candidates who are more likely to benefit from this intervention. The experience gained from this project will guide planning of future confirmatory trials that use relevant clinical outcomes to assess potential benefits of this intervention and utilize important subject- specific parameters to refin study inclusion criteria and aid in severity adjusted analysis.