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

项目简介：吞咽障碍是中风常见的严重并发症，但缺乏有效的治疗方法。本研究拟采用无创脑刺激技术经颅直流电刺激（tDCS）联合吞咽练习改善急性-亚急性脑梗死患者吞咽困难的前瞻性临床研究，并获得2种不同剂量tDCS对吞咽生理和行为的安全性和影响数据。脑半球中风引起的吞咽困难是由于脑干吞咽中枢的皮质投影被破坏，而吞咽功能的恢复是通过未受影响的脑半球吞咽皮层的重组来调节的。我们最近的试点研究表明，在急性-亚急性中风阶段，对未受影响半球的吞咽皮层连续进行5次30分钟的阳极tDCS治疗是安全可行的，并且在吞咽训练的同时显示出改善吞咽困难的希望。拟议的研究将用于进一步确认该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影响吞咽困难卒中患者对我们提出的干预反应的重要的受试者特定参数。本研究的总体目的是收集脑卒中急性-亚急性期tDCS累积疗程的额外安全性数据，获得该干预对重要生理和临床相关吞咽参数的影响信息，检查可能的剂量效应，并确定更有可能从该干预中受益的候选人。从该项目中获得的经验将指导未来验证性试验的规划，这些试验使用相关临床结果来评估该干预措施的潜在益处，并利用重要的受试者特定参数来完善研究纳入标准，并帮助进行严重程度调整分析。

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.