Investigating Epidural Spinal Stimulation to Improve Upper Limb Function After Cervical Spinal Cord Injury Using the CoverEdgeX 32 Surgical Lead System

What this Trial Is About

This research aims to study the effects of cervical epidural spinal stimulation ESS combined with upper extremity training in people with spinal cord injuries SCI. The trial focuses on using the CoverEdgeX 32 Surgical Lead system, an FDA-approved device for pain management but investigational for treating spinal cord injury, to explore its potential in improving upper limb sensorimotor function. The study targets adults aged 22 to 65 with chronic, non-progressive cervical SCI above the T2 level and aims to understand how ESS may support neurological recovery and rehabilitation. The study involves implanting ESS electrodes with external leads in twelve participants during Week 2 after initial screening. Following implantation, participants enter a recovery phase and then undergo detailed assessments of sensorimotor responses, brain activity, and upper limb function. Participants receive ESS therapy combined with upper limb and trunk training during Weeks 5 and 6. Based on their response, some will receive a permanent implantable pulse generator IPG, while non-responders will have the electrodes removed. The stimulation is delivered during study visits for up to 1 hour at varying frequencies and intensities adjusted to elicit muscle responses. Participants will attend multiple visits over approximately 16 weeks, including clinical exams, neuroimaging, electrophysiological assessments, and functional tests to monitor muscle response and neurological status. The study measures upper limb muscle responses at several time points, along with assessments of neurological function and independence. Safety and tolerance are monitored throughout, with rest periods and parameter refinements included. This detailed follow-up aims to evaluate how ESS influences rehabilitation outcomes and brain connectivity after cervical spinal cord injury.

Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord