Evaluating Epidural Electrical Stimulation Combined with Automated Rehabilitation to Improve Motor, Bladder, and Sexual Functions in Adults with Incomplete Spinal Cord Injuries

What this Trial Is About

Neurological disabilities resulting from traumatic spinal cord injuries can cause challenges in movement, bladder, and sexual functions. This trial investigates the use of epidural electrical stimulation EESS combined with locomotor training to restore these functions in adults with incomplete spinal cord injuries. Previous studies in animals and humans have shown promising improvements using this approach, but detailed clinical validation is needed. Participants will undergo two treatment sequences in a crossover design. One sequence involves 40 working days of stimulation combined with automated rehabilitation two 45-minute sessions daily, followed by a 30-day washout, then 40 working days of automated rehabilitation alone. The other sequence reverses this order. This approach aims to compare the effects of adding stimulation to rehabilitation in improving motor and autonomic functions. Throughout the study, participants will be monitored for their ability to move over a distance of 5 meters, as well as improvements in bladder and sexual function. Assessments will include evaluations of spinal neuronal excitability, quality of life, and safety monitoring for adverse events. The study spans several months, including treatment periods, washout phases, and follow-up assessments to capture lasting effects and tolerance.

Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries