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使许多中风幸存者恢复正常步态，导致对 其他的则是反复跌倒、社区活动受限以及生活质量差。此举的主要目标 研究目的是测试一种治疗持续性步态的新方法的功效和神经生理学机制 通过同时进行非侵入性脑刺激和经颅直接刺激相结合，可以改善中风后的缺陷 电流刺激 (tDCS) 和步态训练。理由：外周定向步态疗法的驱动因素是 大脑功能的变化。经颅直流电刺激 (tDCS) 已被证明可以增强康复期间的大脑功能变化，以及 改善结果。其易用性和安全性使 tDCS 成为与同步步态配对的理想技术 训练方法。上肢研究表明，10 次双半球 tDCS 结合 与治疗后的微小变化相比，运动疗法产生了具有临床意义的改善 独自的。我们进行了试点研究，证明了所提出的方案的可行性和耐受性 干涉。我们的第一个单次交叉试点研究证明了 tDCS 结合的潜在好处 与单独的步态治疗相比，进行步态训练。我们的第二次 10 次试点研究表明了该方案的可行性 干预并证明临床改善。下一个重要步骤是随机测试它 对照研究。我们将使用双半球 tDCS 蒙太奇来解决关键的适应性神经可塑性问题 参与中风后运动恢复的机制，即通过 1) 重新平衡半球​​间相互作用 促进下肢残余同侧运动输出通路，2) 抑制 来自对侧运动区的经胼胝体抑制。研究设计：我们将招募 50 名慢性中风患者 具有步态缺陷的受试者（>6 个月）。受试者将被随机分配到 10 次主动 tDCS+步态训练 训练或假 tDCS+步态训练。步态训练将在基于跑步机的虚拟现实中完成 针对瘫痪肢体更长的单肢姿势的环境。目标 1 是确定是否 同时进行经颅直流电刺激 (tDCS) 和步态训练相结合可显着改善步态表现 与单独的步态训练相比。主要结果指标将是步态速度（通过 10- 米步行测试（TMWT）和麻痹单肢站立持续时间。次要结果指标将评估 步态相关功能域的各个组成部分，包括以下内容： 时空步态 不对称；另一种与步态速度相关的措施（计时起行（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）；感官测量- 运动障碍（Fugl-Meyer）；功能步态测量（功能步态评估）；和动态平衡 （迷你最佳测试）。目标 2 是表征响应双半球 tDCS 的神经可塑性大脑变化 结合步态训练。结果测量为 1) 同侧皮质脊髓兴奋性（运动诱发 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（静息态功能磁共振 成像（rs-fMRI））。目标 3 是确定预测步态 tDCS 反应的步态改善因素 训练。我们将评估步态速度的变化与麻痹单肢姿势之间的关系 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 诱导电流密度建模。意义： 这项研究将解决 VA 患者群体的一个重要问题。我们将第一次测试 双半球 tDCS 是否可以增强慢性卒中的步态训练并评估神经可塑性 这种治疗方法涉及的机制。 tDCS 与基于 VR 的高效步态训练相结合 一种新颖的治疗方法，由有希望的初步数据驱动并得到 多学科专业知识。