Contralaterally Controlled FES Combined with Brain Stimulation for Severe Upper limb Hemiplegia

项目摘要/摘要 制定对重症患者既有效又合适的康复干预措施 上肢瘫痪仍然是临床上尚未得到满足的主要需求。这些病人很少或根本没有意志力运动。 因此留下的是没有功能的上肢。许多康复疗法都不适合这种情况。 这是因为他们需要大量的剩余流动。我们已经开发并测试了一种新的 可以在手/手指几乎没有残留运动的患者中进行的治疗。被称为对侧 受控功能电刺激(CCFES)，该技术应用神经肌肉电刺激 (NME)到瘫痪的手腕、手指和拇指伸肌，以产生手部张开。病人控制着 在未受影响的对侧手上戴上带有传感器的手套，以达到刺激强度。当 病人张开他们未受影响的手，成比例的刺激强度张开他们偏瘫的手。因此， 瘫痪的手不需要残留的运动，这使得即使是严重的瘫痪患者也可以 使用受影响的上肢进行功能任务练习。我们在最近的一次随机对照试验中表明，CCFES 在减少重症患者上肢运动障碍方面，NMES比传统NMES更有效。但 患者继续感受到功能能力的限制。本研究的目标是在已有成果的基础上再接再厉 通过使用我们已经展示的另一种技术来增强CCFES的效果，从而在重症患者中实现CCFES 促进这一亚群的改善。提供无创脑刺激，方便完好 对侧高级运动皮质(CHMC)对重症患者上肢运动控制有积极作用 病人。当广泛损害同侧皮质脊髓通路使受损的同侧脊髓 初级运动皮质(IM1)在控制偏瘫肢体运动方面无效，完整的对侧运动皮质 特别是CHMC可以通过改变运动之间的半球间抑制平衡来起作用。 并通过增加从对侧皮质到偏瘫患者的非交叉投射的兴奋性 上肢。因此，在这里，我们将检验CCFES通过CHMC的促进而增强的科学前提 与CCFES增强相比，重症患者的上肢运动改善更大 常规的iM1或CCFES的促进作用。72名严重手损伤患者将 接受CCFES+CHMC促进、CCFES+iM1促进或CCFES+假脑治疗12周 刺激。上肢运动功能和神经生理学评估将在基线时完成，6， 12周、24周和36周。这项研究将1)确定CHMC易化是否增强CCFES的作用 为了使重症患者的上肢功能得到更大的改善，2)调查潜在的 有助于恢复偏瘫肢体运动控制的神经生理机制，以及3)评估和识别 影响CCFES+CHMC易化疗效的患者因素。 好了！

PROJECT SUMMARY/ABSTRACT Development of rehabilitation interventions that are both effective and appropriate for patients with severe upper limb paresis remains a major unmet clinical need. These patients have little to no volitional movement and therefore are left with a non-functional upper limb. Many rehabilitation therapies are inappropriate for this sub-population because they require significant residual movement. We have developed and tested a new therapy that can be delivered in patients with little to no residual hand/finger motion. Known as contralaterally controlled functional electrical stimulation (CCFES), the technique applies neuromuscular electrical stimulation (NMES) to paretic wrist, finger, and thumb extensors to produce hand opening. The patient controls the intensity of stimulation by wearing a glove with sensors on their unaffected contralateral hand. When the patient opens their unaffected hand, a proportional intensity of stimulation opens their paretic hand. Therefore, no residual movement of the paretic hand is necessary, which allows even patients with severe paresis to engage in functional task practice using the affected upper limb. We have shown in a recent RCT that CCFES is more effective than conventional NMES at reducing upper limb motor impairment in severe patients. But patients continue to experience limitation in functional abilities. The goal of this study is to build upon the gains achieved with CCFES in severe patients by augmenting its effects with another technique we have shown to facilitate improvements in this sub-population. Non-invasive brain stimulation delivered to facilitate the intact contralesional higher-motor cortices (cHMC) can have positive effects on upper limb motor control in severe patients. When extensive damage to ipsilesional corticospinal pathways renders the damaged ipsilesional primary motor cortex (iM1) ineffective at controlling paretic limb movement, intact, contralesional motor cortices especially the cHMC can contribute by changing the balance of interhemispheric inhibition between motor cortices and by increasing the excitability of uncrossed projections from the contralesional cortex to the paretic upper limb. Therefore, here, we will test the scientific premise that CCFES augmented with facilitation of cHMC will lead to greater upper limb motor improvement in severe patients than CCFES augmented with conventional facilitation of iM1 or than CCFES alone. Seventy-two patients with severe hand impairment will receive 12 weeks of CCFES + cHMC facilitation, CCFES + iM1 facilitation, or CCFES + sham brain stimulation. Assessments of upper limb motor function and neurophysiology will be completed at baseline, 6, 12, 24, and 36 weeks. This study will 1) determine whether cHMC facilitation augments the effects of CCFES to produce greater improvements in upper limb function in severe patients, 2) investigate the underlying neurophysiologic mechanisms contributing to restored paretic limb motor control, and 3) evaluate and identify patient factors that affect efficacy of CCFES + cHMC facilitation. !