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

恢复脊髓损伤(SCI)后的运动能力一直是多年来旨在 改善了几种与健康相关的并发症。脊髓硬膜外刺激(SCES)显示 脊髓损伤患者结合强化运动后恢复运动的康复潜力 训练。尽管有这种潜力，但当在大型临床脊髓损伤中应用时，这样的方案可能是不切实际的 由于高昂的货币成本，人口数量不断增加。与SCES类似，经脊髓刺激(TS)也表现出 外部刺激腰-骶神经环路产生阶梯式活动对神经调节的好处 对于完全性脊髓损伤患者，这些技术也需要高强度的步态训练。最近的机器人 外骨骼已经被用作一种有希望的工具，以绕过与劳动密集型相关的限制 运动训练，并已被安全地用作提高体力活动水平的有效方法 患有完全性脊髓损伤的人。 最近的工作证明了EAW和神经调节技术相结合的好处。跟随 12周的EAW+SCES训练，运动能力的改善导致研究人员减少了 在C7完全性脊髓损伤患者中，EAW摆动援助增加到35%。随行的还有573名无人协助的人 步骤数，占该届会议期间所采取步骤总数的50%。肌电(EMG) 在站立和挥杆阶段，活动量都会增加，这反映了个人有节奏地 在EAW+SCES过程中，火使肌肉瘫痪。此外，心脏代谢负荷在 与不使用SCES的外骨骼踏步相比，外骨骼踏步与SCES联合踏步的效果比较。参与者还 显示他的总脂肪量和局部绝对脂肪质量略有下降。这些初步调查结果表明， 使用SCES结合外骨骼步行进行神经调节可能提供一种可行的康复途径 患有脊髓损伤的人。当前研究的目标是检查和比较EAW联合作用的效果 运动性完全性脊髓损伤患者的SCES或TS。此应用程序生成的数据还将启用 更大规模的临床试验，探索通过使用不同的方法优化外骨骼辅助步态训练的方法 脊髓损伤的神经调节方式。 按照重复测量设计，10名慢性运动完全性(AIS A和B)脊髓损伤的参与者 (18-60岁)将被随机分配参加为期6个月的EAW+SCES(n=5)或 EAW+TS(n=5)训练。每个参与者的整个试用期约为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，再进行6个月的训练(均为 两组均为3次/周)，随访期均为3个月。基线上的测量值(BL： EAW前)和干预后4个时间点每3个月发生一次(P1：EAW后3个月； P2：EAW+TS或EAW+SCES后3个月；P3：完成EAW+TS或 EAW+SCES；P4：EAW+TS或EAW+SCES终止后3个月。这项试点工作将有3个具体的 目标：目标1。我们将确定并比较以下6个月后运动控制的改善情况 通过10米步行速度测量EAW+TS和EAW+SCES，无辅助EAW步数， 和肌电活动。目标2：我们将确定和比较心脏代谢风险因素的改善情况 在EAW+TS和EAW+SCES的6个月后，用全身和局部身体成分、氧气 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 术后6个月行EAW+TS和EAW+SCES膀胱充盈和排空测定。

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.