Transcranial Direct Current stimulation for post-stroke gait rehab

经颅直流电刺激用于中风后步态康复

• 批准号: 10704996
• 负责人: SVETLANA PUNDIK
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-10-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10704996
• 关键词: Activities of Daily Living; Address; Admission activity; Affect; American; Anodes; Area; Bilateral; Brain; Brain Stem; Caregivers; Caring; Chronic; Clinical; Cohort Studies; Communities; Corticospinal Tracts; Cross-Over Studies; Data; Dependence; Diffusion Magnetic Resonance Imaging; Distal; Electrodes; Enrollment; Equilibrium; Exhibits; Functional Magnetic Resonance Imaging; Future; Gait; Gait speed; Impairment; Individual; Intervention; Intervention Studies; Investigation; Ipsilateral; Lesion; Limb structure; Lower Extremity; Measures; Methods; Minor; Modeling; Motor; Motor Cortex; Motor Evoked Potentials; Motor output; Movement; Neuronal Plasticity; Outcome Measure; Paresis; Pathway interactions; Performance; Peripheral; Personal Satisfaction; Physical therapy; Pilot Projects; Predictive Factor; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Reaction; Recovery; Recurrence; Rehabilitation Outcome; Rehabilitation therapy; Research Design; Residual state; Rest; Safety; Sensory; Stroke; Technology; Testing; Therapeutic; Time; Training; Upper Extremity; Walking; arm; chronic stroke; clinically significant; cost; density; design; disability; effectiveness study; fall risk; falls; follow-up; gait rehabilitation; high risk; improved; improved outcome; insight; kinematics; meter; military veteran; motor impairment; motor learning; motor recovery; multidisciplinary; neurological rehabilitation; neurophysiology; noninvasive brain stimulation; novel; novel strategies; novel therapeutic intervention; patient population; post stroke; primary outcome; randomized, controlled study; recruit; response; secondary outcome; spatiotemporal; stroke rehabilitation; stroke survivor; tool; transcranial direct current stimulation; treadmill; virtual reality environment

Current rehabilitation methods fail to restore normal gait for many stroke survivors leading to dependence on others, recurrent falls, limitations in community ambulation and poor quality of life. The main objective of this study is to test both efficacy and neurophysiological mechanisms of a novel approach to treat persistent gait deficits after stroke with a combination of simultaneous non-invasive brain stimulation with transcranial Direct Current Stimulation (tDCS) and gait training. Rationale: Peripherally directed gait therapies are driven by functional brain changes. tDCS has been shown to enhance functional brain changes during rehabilitation and improve outcomes. Its ease of use and safety makes tDCS an ideal technology to pair with simultaneous gait training methods. Upper limb studies showed that 10-session bihemispheric tDCS in combination with movement therapy produced clinically meaningful improvement compared with minor changes after therapy alone. We conducted pilot studies that demonstrated both feasibility and tolerability of the proposed intervention. Our first single-session crossover pilot study demonstrated a potential benefit of tDCS combined with gait training compared with gait therapy alone. Our second 10-session pilot study showed feasibility of the intervention and demonstrated clinical improvements. The next important step is to test it in a randomized control study. We will use a bihemispheric tDCS montage that can address a key adaptive neuroplastic mechanism involved in post-stroke motor recovery, that is rebalancing interhemispheric interaction by 1) facilitation of the residual ipsilesional motor output pathways for the lower extremity and 2) suppression of transcallosal inhibition from the contralesional motor regions. Study Design: We will enroll 50 chronic stroke subjects (>6 months) with gait deficits. Subjects will be randomized to 10 sessions of either active tDCS+gait training or sham tDCS+gait training. Gait training will be accomplished in the treadmill-based Virtual Reality environment targeting longer single limb stance with the paretic limb. Aim 1 is to determine whether the combination of simultaneous tDCS and gait training produces greater improvement in gait performance compared to gait training alone. The primary outcome measure will be both gait speed as measured by 10- Meter Walk test (TMWT) and paretic single limb stance duration. Secondary outcome measures will assess various components of gait-related functional domains and will include the following: spatiotemporal gait asymmetry; another gait-speed-related measure (Timed Up and Go (TUG)); Ground Reaction Force; gait kinematics; a measure of gait coordination (Gait Assessment and Intervention Tool); a measure of sensory- motor impairment (Fugl-Meyer); a functional gait measure (Functional Gait Assessment); and dynamic balance (miniBEST test). Aim 2 is to characterize the neuroplastic brain changes in response to bihemispheric tDCS combined with gait training. Outcome measures are 1) ipsilateral corticospinal excitability (motor evoked potential recruitment curve (MEP-rc)),2) asymmetry of interhemispheric excitability (bilateral MEP-rc ratio), 3) functional connectivity between bilateral primary motor regions (resting state functional Magnetic Resonance Imaging (rs-fMRI)). Aim 3 is to identify factors that predict gait improvement in response to tDCS with gait training. We will evaluate the relationship between changes in gait speed and paretic single limb stance duration and baseline assessment of structural and functional reserve (according to corticospinal tract lesion load, clinical impairment, functional connectivity) and tDCS induced current density modeling. Significance: This study will address an important problem for the VA patient population. We will test for the first time whether bihemispheric tDCS can enhance gait training in chronic stroke and evaluate neuroplastic mechanisms involved in this therapeutic approach. Combination of tDCS and efficient VR-based gait training is a novel therapeutic approach that is being driven by promising preliminary data and supported by multidisciplinary expertise.

目前的康复方法无法恢复许多中风幸存者的正常步态，导致依赖于 其他的是经常性福尔斯、社区活动受限和生活质量差。的主要目标 本研究旨在测试一种治疗持续性步态的新方法的疗效和神经生理学机制 同时无创脑刺激与经颅直接电刺激相结合治疗卒中后的功能障碍 电流刺激（tDCS）和步态训练。理由：外周引导步态治疗由以下因素驱动： 大脑功能改变tDCS已经显示出在康复期间增强功能性脑变化， 改善成果。它的易用性和安全性使tDCS成为一种理想的技术，以配合同时步态 培训方法。上肢研究表明，10次双半球tDCS联合 运动疗法产生临床意义的改善相比，治疗后的微小变化 一个人我们进行了试点研究，证明了可行性和耐受性的建议， 干预我们的第一个单次交叉试验研究证明了tDCS结合 与单独的步态治疗相比。我们的第二个10期试点研究表明， 干预和临床改善。下一个重要的步骤是在一个随机 对照研究我们将使用双半球tDCS蒙太奇，可以解决一个关键的适应性神经可塑性 中风后运动恢复的机制，即通过1）重新平衡半球间的相互作用 促进下肢的残余同侧运动输出通路和2）抑制 对侧运动区的胼胝体抑制。研究设计：我们将入组50例慢性卒中患者 受试者（>6个月）有步态缺陷。受试者将随机接受10次主动tDCS+步态治疗 训练或假tDCS+步态训练。步态训练将在基于计算机的虚拟现实中完成 环境目标较长的单肢站姿与麻痹肢体。目标1是确定 同时tDCS和步态训练的组合产生步态性能的更大改善 与单独的步态训练相比。主要结局指标将是步态速度，通过10- 米步行试验（TMWT）和麻痹单肢站立持续时间。次要结局指标将评估 步态相关功能域的各种组成部分，并将包括以下内容： 不对称;另一种与步态速度相关的测量（计时起身和行走（TUG））;地面反作用力;步态 运动学;步态协调的测量（步态评估和干预工具）;感觉- 运动障碍（Fugl-Meyer）;功能性步态测量（功能性步态评估）;和动态平衡 （miniBEST测试）。目的2是描述双半球tDCS引起的神经可塑性脑变化 结合步态训练。结果测量是1）同侧皮质脊髓兴奋性（运动诱发的 潜在募集曲线（MEP-rc）），2）半球间兴奋性的不对称性（双侧MEP-rc比率），3） 双侧初级运动区之间的功能连接（静息状态功能磁共振 成像（rs-fMRI））。目的3是确定预测步态改善的因素，以响应tDCS与步态 训练我们将评估步态速度的变化和麻痹单肢站立之间的关系 结构和功能储备的持续时间和基线评估（根据皮质脊髓束病变 负载、临床损伤、功能连接）和tDCS诱导的电流密度建模。重要性： 本研究将解决VA患者人群的一个重要问题。我们将首次测试 双半球tDCS是否可以增强慢性卒中患者的步态训练并评估神经可塑性 参与这种治疗方法的机制。结合tDCS和基于VR的高效步态训练， 一种新型治疗方法，由有希望的初步数据驱动并得到以下支持 多学科的专业知识。