Comparing Non-Invasive and Implantable Spinal Stimulation to Improve Standing and Mobility After Spinal Cord Injury in Adults Aged 22 to 75

What this Trial Is About

Researchers are studying how two types of spinal cord stimulation, epidural spinal stimulation ESS and transcutaneous spinal stimulation TSS, can help people with complete motor paralysis regain the ability to stand and control their lower limbs after a spinal cord injury. This study aims to understand the different physiological effects of these two stimulation methods and compare their impact on maintaining self-assisted standing in individuals with chronic spinal cord injury. The investigation focuses on improving motor function and mobility through targeted neuromodulation approaches. Participants will receive spinal stimulation either through a non-invasive method using surface electrodes placed on the skin TSS or through an implanted device delivering epidural stimulation ESS. There is also a sham stimulation group where stimulation intensity is gradually reduced to zero during sessions. The study involves randomized assignment to these groups, with stimulation delivered during research visits. The ESS device involves surgery to implant and later remove the stimulator. The study also includes activity-based training combined with stimulation to assess therapeutic effects. During the study, participants will be evaluated at multiple time points including baseline, post-intervention, and follow-up weeks. Assessments include measuring force generated by the lower limbs, neurological status, and independence in daily activities. Participants must tolerate supported standing and perform self-transfers. Safety is monitored throughout, and participants are followed for several weeks after interventions to observe sustained effects. The total study duration includes baseline assessments, intervention delivery, and follow-up evaluations.

Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury