Initial feasibility evaluation of the RISES system: An innovative and activity-based closed-loop framework for spinal cord injury rehabilitation and recovery

Background: Electrical stimulation of the spinal cord may improve rewiring of the affected pathways. Immediate modulation of stimulation parameters, and its effects of it on kinematics and electromyographic variables is unclear. Methods: This study piloted the safety and feasibility of the Reynolds Innovative Spinal Electrical Stimulation (RISES) technology with a focus on its novel closed-loop setting. This personalized, task-specific non-invasive stimulation system enables real-time stimulation parameter modulation and supports multi-data acquisition and storage. Four SCI participants underwent a clinical trial coupled with activity-based training. Primary safety outcome measures included adverse events (AEs) and skin integrity; secondary measures were vital signs, pain, and fatigue assessed at the pre, mid, and post-stimulation sessions. The trial included open-loop and closed-loop blocks of transcutaneous spinal cord stimulation (tSCS). Results: Results showed no serious adverse events, with skin integrity unaffected. Vital signs and pain showed no significant differences across session timepoints. Fatigue levels differed significantly with post-session > mid-session > pre-session. Comparisons between open-loop and closed-loop blocks showed no significant differences in setup time, vital signs, pain, or fatigue. Average stimulation duration per task was significantly longer for open-loop (467.6 sec) than Closed-loop (410.8 sec). Conclusions: RISES, demonstrated safety and feasibility. Further work will focus on clinical efficacy.