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.

当前的康复方法无法恢复许多中风幸存者的正常步态 其他，反复出现的跌倒，社区流动的局限性和生活质量差。主要目标 研究是为了测试一种治疗持续步态的新方法的功效和神经生理机制 中风后缺陷，同时非侵入性脑刺激与经颅直接 当前刺激（TDC）和步态训练。理由：外围导向步态疗法由 功能性大脑变化。已显示TDC可在康复过程中增强功能性大脑的变化和 改善结果。它的易用性和安全性使TDCS成为同时步态配对的理想技术 培训方法。上肢的研究表明，有10次分发的Bihamispheric TDC与 与治疗后的微小变化相比，运动疗法在临床上产生有意义的改善 独自的。我们进行了试点研究，证明了所提出的可行性和耐受性 干涉。我们的第一个单课跨界试验研究表明，TDC的潜在优势合并 与仅步态疗法相比，步态训练。我们的第二次10期试点研究表明 干预并显示出临床改进。下一个重要步骤是在随机的 控制研究。我们将使用可以解决关键自适应神经塑性的Bihemispheric TDCS蒙太奇 冲程后运动恢复涉及的机制，即将半球间相互作用重新平衡1） 为下肢的剩余iPsilesitial电动机输出途径的促进和2）抑制 对侧运动区域的触及抑制作用。研究设计：我们将注册50个慢性中风 受试者（> 6个月）患有步态缺陷。受试者将随机分为10个活动的TDC+步态的10个会话 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 靶向更长的肢体姿势的环境。目标1是确定是否 同时进行TDC和步态训练的结合可在步态性能方面有更大的改善 与仅步态训练相比。主要结局指标将是步态速度，如10- 仪表步行测试（TMWT）和偏度单肢立场持续时间。次要结果措施将评估 步态相关功能域的各种组成部分，将包括以下内容：时空步态 不对称；另一种与步态速度相关的度量（时机上并进行（拖线））；地面反应力；步态 运动学；步态协调的度量（步态评估和干预工具）；感觉的量度 运动障碍（Fugl-Meyer）；功能步态度量（功能步态评估）；和动态平衡 （最小测试）。 AIM 2是表征神经塑性大脑对生物球TDC的响应的变化 结合步态训练。结果指标是1）同侧皮质脊髓兴奋性（诱发了电动机 潜在的募集曲线（MEP-RC）），2）半球间兴奋性（双侧MEP-RC比）的不对称性，3） 双侧初级运动区域之间的功能连通性（静止状态功能磁共振 成像（RS-FMRI））。 AIM 3是确定可以预测步态TDC的步态改善的因素 训练。我们将评估步态速度变化与偏度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（根据皮质脊髓病变 负载，临床障碍，功能连通性）和TDCS诱导电流密度建模。意义： 这项研究将解决VA患者人群的重要问题。我们将首次测试 Bihamispheric TDC是否可以增强慢性中风的步态训练并评估神经塑性 这种治疗方法涉及的机制。 TDCS和有效的基于VR的步态训练的组合是 一种新型的治疗方法，该方法是由有希望的初步数据驱动的，并由 多学科专业知识。