Transspinal versus Epidural Stimulation for Exoskeletal Assisted Walking after Spinal Cord Injury

脊髓损伤（SCI）后恢复运动一直是多年研究的焦点， 改善几种与健康相关的合并症。脊髓硬膜外刺激（SCES）表现出 当与强化运动相结合时，SCI患者恢复运动的康复潜力 训练尽管有这种潜力，但当应用于大型临床SCI时，此类方案可能不切实际 由于货币成本高。与SCES类似，经脊髓刺激（TS）也表现出 通过外部刺激腰骶神经环路产生阶梯样活动的神经调节益处 然而，这些技术也需要高强度的步态训练。最近机器人 外骨骼已经被用作一种有前途的工具， 运动训练，并已被安全地用作提高身体活动水平的有效方法 完全SCI患者。 最近的工作已经证明了EAW和神经调节技术相结合的好处。以下 12-在为期两周的EAW+SCES训练中，运动的改善导致研究人员减少了 C7完全SCI患者的EAW挥杆辅助为35%。这是伴随着573无人协助 步骤，占该届会议期间采取的步骤总数的50%。肌电图（EMG） 在站立和摆动阶段，活动也增加了，反映了个体有节奏地运动的能力。 在EAW+SCES期间激发麻痹的肌肉。此外，心脏代谢负荷增加， 与没有SCES的踏步相比，与SCES结合时的外骨骼踏步。该与会者还 显示他的总脂肪量和局部绝对脂肪量适度减少。这些初步调查结果表明， 使用SCES和外骨骼肌进行神经调节可能为神经功能缺损提供可行的康复方法。 SCI患者。本研究的目的是检查和比较EAW联合 运动完全性SCI患者的SCES或TS。此应用程序生成的数据还将使 更大的临床试验，以探索通过使用不同的 神经调节方式与SCI 在重复测量设计后，10名患有慢性运动完全性（AIS A和B）SCI的参与者 (age：18-60岁）将被随机分配参加6个月的EAW+SCES（n=5）或 EAW+TS（n=5）训练。每例受试者的整个试验持续时间约为1年。 最初，参与者将接受为期3个月的EAW培训（每周3次），随后将 随机分为EAW+SCES组或EAW+TS组，接受额外6个月的培训（均 组：3次/周）和3个月的随访期。基线测量值（BL： 每3个月发生4个干预后时间点（P1：EAW后3个月; P2：3个月的EAW+TS或EAW+SCES后; P3：完成6个月的EAW+TS或 EAW+SCES; P4：EAW+TS或EAW+SCES终止后3个月）。本次试点工作将有3个具体 目标：目标1。我们将确定并比较6个月后运动控制的改善情况， EAW+TS和EAW+SCES，通过10米步行速度、无辅助EAW步数、 EMG活动。目标2.我们将确定并比较心脏代谢危险因素的改善情况 在EAW+TS和EAW+SCES 6个月后，通过总的和局部的身体组成、氧 摄取和空腹血脂谱。目标3.我们将确定和比较膀胱健康的改善 EAW+TS和EAW+SCES治疗6个月后，通过膀胱充盈和排空测量。

Restoring locomotion following spinal cord injury (SCI) has been the focus of years of research aimed at ameliorating several of health-related comorbidities. Spinal cord epidural stimulation (SCES) exhibits the rehabilitation potential of restoring locomotion in individuals with SCI when combined with intensive locomotion training. Despite this potential, such protocols are likely impractical when applied across large clinical SCI populations due to high monetary costs. Similar to SCES, transspinal stimulation (TS) has also exhibited neuromodulatory benefits by externally stimulating lumbro-sacral neural circuity to generate step-like activities in persons with complete SCI; however, these techniques also require intense gait training. Recently robotic exoskeletons have been used as a promising tool to circumvent limitations associated with labor-intensive locomotor training, and have been safely used as an effective approach in improving levels of physical activity in persons with complete SCI. Recent work has demonstrated the benefits of combining EAW and neuromodulatory techniques. Following 12-weeks of EAW+SCES training, improvements in locomotion led researchers to decrease the amount of EAW swing assistance to 35% in a person with a C7 complete SCI. This was accompanied by 573 unassisted steps, which represents 50% of the total number of steps taken during that session. Electromyographic (EMG) activity also increased during both stance and swing phases, reflecting the individual’s ability to rhythmically fire paralyzed muscles during EAW+SCES. Additionally, cardio-metabolic loads were increased during exoskeletal stepping when combined with SCES as compared to stepping without SCES. The participant also showed a modest decrease in his total and regional absolute fat mass. These preliminary findings suggest that neuromodulation using SCES with exoskeletal ambulation may provide a feasible rehabilitation approach for persons with SCI. The goal of the current study is to examine and compare the effects of EAW combined with SCES or TS in persons with motor complete SCI. The data generated from this application will also enable larger clinal trials to explore ways to optimize exoskeletal assisted gait training through the use of different neuromodulation modalities with SCI. Following a repeated-measure design, 10 participants with chronic, motor complete (AIS A and B) SCI (age:18-60 years) will be randomly assigned to participate in either 6-months of EAW+SCES (n=5) or EAW+TS (n=5) training. The entire duration of the trial will be approximately 1 year for each participant. Initially, participants will undergo 3-months of EAW training (3 sessions/week), which will be followed by randomization into either a EAW+SCES group or EAW+TS group for an additional 6-months of training (both groups: 3 sessions/week) and a 3-month follow-up period for both groups. Measurements at baseline (BL: prior to EAW) and 4 post-intervention timepoints will occur every 3-months (P1: following 3-months of EAW; P2: following 3-months of EAW+TS or EAW+SCES; P3: after completing 6-months of EAW+TS or EAW+SCES; P4: 3-months after termination of EAW+TS or EAW+SCES). This pilot work will have 3 specific aims: Aim 1. We will determine and compare improvements to locomotor control following 6 months of EAW+TS and EAW+SCES as measured by 10-meter walking speed, the number of unassisted EAW steps, and EMG activity. Aim 2. We will determine and compare improvements to cardio-metabolic risk factors following 6 months of EAW+TS and EAW+SCES as measured by total and regional body composition, oxygen uptake, and fasting lipid profile. Aim 3. We will determine and compare improvements in bladder health following 6 months of EAW+TS and EAW+SCES as measured by bladder filling and emptying.