Spinal reflex conditioning system for enhancing motor function recovery after incomplete spinal cord injury

项目摘要 因慢性脊髓损伤(SCI)而痉挛的患者可以从反射操作剂中受益 条件疗法，如家长申请中所述。经皮刺激术 胫神经，我们正在实施的比目鱼肌H反射条件反射的基本要素，可以 产生因人而异的不适。这种不适是最小的，也是可以忍受的。 在大多数经历过这种情况的人身上。然而，在高达20%的人中，来自 刺激是不容易容忍的。因此，不能实施刺激程序 而患者可能会选择不接受条件反射治疗。例如，具有以下特征的个人 脊髓损伤或对经皮刺激过敏的个人引起的慢性疼痛可能是 更容易感受到皮肤表面刺激带来的不适。将这些排除在外 来自潜在患者群体的个体并不理想，但到目前为止已经被容忍， 因为刺激不适是一个长期存在的问题，并不是我们的程序所独有的，而且因为 大多数候选患者确实选择接受操作性条件反射治疗 体验它的好处。 我们最近意外地发现，表面刺激与适当的调谐 多电极配置可以减少患者的不适。通过整合可定制的 我们建议将多电极刺激配置控制到我们的反射条件反射系统中 减少刺激性不适的发生率。这种刺激性不适的减少将 扩大我们正在翻译的反射操作性条件反射疗法的候选患者基础 投入临床使用，这样更多的患者可能会从中受益。 为了提高患者在刺激期间的舒适性，同时保持相同的效果 在H反射激发作为标准的单电极刺激中，我们提出了三个目标。目标1 将评估并最终确定为刺激舒适性而优化的刺激电极阵列设计， 可用性和有效性。我们将通过收集系列试验的反馈来实现这一目标 在不同腿部尺寸的志愿者身上，使用三种不同的电极设计迭代。目标 2将检查不同刺激电极的有效性、知觉和舒适度 在没有神经系统疾病的志愿者中进行配置。这一目标将缩小参数范围 使招募最大化和最小化的电势电极配置的空间 不舒服。AIM 3将在患有神经疾病的患者身上测试这些最佳配置。 这一目标将确认是否至少一种多电极配置将产生更少的 比常规单电极刺激更不舒服。这一目标也将确认是否 经历过刺激不适的人更有可能 选择接受延长的操作性条件反射疗法。 拟议的行政补充将使我们能够利用意想不到的 增加患者舒适度的机会与我们现在的反射条件疗法有关 转送到诊所。这一进展应该会加强临床传播和采用 新系统并扩大可从中受益的患者群体。这些好处应该是 大大增加了项目的最终实用价值，并与其同行一致- 回顾了目标。

Project Summary People with spasticity due to chronic Spinal Cord Injury (SCI) can benefit from reflex operant conditioning therapy, as described in the parent application. Transcutaneous stimulation of the tibial nerve, an essential element of the soleus H-reflex conditioning we are implementing, can produce discomfort that varies from person to person. This discomfort is minimal and tolerable in most individuals who experience it. In up to 20% individuals, however, the discomfort from stimulation is not easily tolerable. As a result, the stimulation procedure cannot be administered and the individual may opt out of reflex conditioning therapy. For example, individuals with chronic pain due to SCI or individuals with hypersensitivity to transcutaneous stimulation can be more prone to experience discomfort from skin-surface stimulation. The exclusion of these individuals from the potential patient population is not ideal, but has been tolerated to date, because stimulation discomfort is a longstanding issue not unique to our procedures, and because the majority of candidate patients do elect to undergo operant conditioning therapy and experience its benefits. We recently made the unexpected discovery that surface stimulation with appropriately tuned multi-electrode configurations can reduce patient discomfort. By incorporating customizable control of multi-electrode stimulus configuration into our reflex conditioning system we propose to reduce the incidence of stimulation discomfort. This reduction of stimulation discomfort would expand the candidate patient base for the reflex operant conditioning therapy we are translating into clinical use, so that many more patients might benefit from it. In order to improve patient comfort during stimulation, while maintaining the same effectiveness in H-reflex elicitation as the standard single electrode stimulation, we propose three aims. Aim 1 will evaluate and finalize a stimulating electrode array design optimized for stimulation comfort, usability, and effectiveness. We will accomplish this aim by gathering feedback from serial trials on volunteers with various leg dimensions, using three different electrode design iterations. Aim 2 will examine the effectiveness, perception, and comfort level of different stimulation electrode configurations in volunteers with no neurological conditions. This aim will narrow the parameter space of potential electrode configurations which maximize recruitment and minimize discomfort. Aim 3 will test these optimal configurations on patients with neurological conditions. This aim will confirm whether at least one of the multi-electrode configurations will produce less discomfort than the conventional single-electrode stimulation. This aim will also confirm whether there is an increased probability that individuals who experience stimulation discomfort would elect to undergo extended operant conditioning therapy. The proposed administrative supplement will allow us to take advantage of the unanticipated opportunity to increase patient comfort involved with the reflex conditioning therapy that we are translating to the clinic. This advance should enhance clinical dissemination and adoption of the new system and expand the patient population that can benefit from it. These benefits should greatly increase the ultimate practical value of the project and are consistent with its peer- reviewed objectives.