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

无创脑刺激促进吞咽困难中风后吞咽恢复

• 批准号: 9061404
• 负责人: Sandeep Kumar
• 金额: $ 54.04万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-14 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9061404
• 关键词: Acute; Adverse event; Aspiration Pneumonia; Assessment tool; Behavior; Brain; Brain Stem; Brain imaging; Caring; Cessation of life; Clinical; Clinical Research; Cohort Studies; Complication; Corticobulbar Tracts; Data; Deglutition; Deglutition Disorders; Deterioration; Diet; Dose; Eating; Exercise; Foundations; Future; Gastrointestinal Hemorrhage; Gastrostomy; Health; Imaging Techniques; Impairment; Incidence; Infarction; Injury; Intake; Intervention; Lead; Lesion; Location; Measures; Mediating; Modeling; Motor Cortex; Neurologic; Oral; Outcome; Pathway interactions; Patient Selection; Patient-Focused Outcomes; Patients; Penetration; Persons; Phase; Physiological; Physiology; Pilot Projects; Recovery; Research; Research Design; Risk; Safety; Seizures; Severities; Stroke; Subgroup; Techniques; Tube; United States National Institutes of Health; acute stroke; chronic stroke; clinically relevant; cost; effective therapy; experience; improved; improved functioning; inclusion criteria; intervention effect; mortality; neuroimaging; neuronal excitability; neuroregulation; novel; nutrition; prevent; prospective; response; treatment response

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.

描述（由申请人提供）： 项目摘要：吞咽障碍是中风常见且严重的并发症，但缺乏有效的治疗方法。我们在此建议进行一项前瞻性临床研究，使用非侵入性脑刺激技术，阳极经颅直流电刺激（tDCS），结合吞咽练习来改善急性亚急性半球梗死引起的吞咽困难，并获得两种不同剂量的tDCS对吞咽生理和行为的安全性和影响的数据。半球中风引起的吞咽困难是由于脑干吞咽中心的皮层投射破坏而发生的，而吞咽功能的恢复已被证明是通过未受影响的半球吞咽皮层的重组来介导的。我们最近的初步研究表明，在急性-亚急性卒中阶段，每天连续 5 次对未受影响半球的吞咽皮层进行 30 分钟的阳极 tDCS 治疗是安全可行的，并且与吞咽练习相结合，有望改善吞咽困难。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中进行检查之前探索替代的、更有效的剂量来促进吞咽恢复。我们将利用我们的研究队列来检查重要的特定于受试者的参数，这些参数会影响我们对吞咽困难中风患者提出的干预措施的反应。本研究的总体目的是收集关于中风急性-亚急性期 tDCS 累积疗程的额外安全性数据，获取有关该干预措施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，并确定更有可能从该干预措施中受益的候选人。从该项目中获得的经验将指导未来验证性试验的规划，这些验证性试验使用相关的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性调整分析。