Epidural Electrical Stimulation to Restore Movement and Sensation in Adults with Spinal Cord Injury

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Epidural Electrical Stimulation EES for improving motor and sensory function in people with chronic spinal cord injuries classified as ASIA B-D. The study focuses on whether EES can significantly enhance motor and sensory abilities compared to before treatment and assess the safety of this approach. Participants include adults aged 16 to 60 years with spinal cord injuries above the T10 level that have been present for 8 to 36 months without recent motor improvement. Participants will undergo surgical implantation of the EES device in the epidural space. After implantation, the device will be activated and personalized stimulation settings adjusted over follow-up visits. Alongside EES, participants will receive standard rehabilitation therapies such as physical and occupational therapy for six months. The study includes regular assessments of motor and sensory function and quality of life at baseline, immediately after device activation, and at 1, 3, and 6 months post-surgery. During the study, participants will complete scheduled tests including walking ability scales and independence measures, as well as evaluations of neurological function, muscle tone, pain, and mood using standardized scales. They will also report any adverse events and attend rehabilitation training sessions while using the EES device. Monitoring occurs at multiple timepoints to track changes over six months, with the goal of understanding EESs impact on function and quality of life in spinal cord injury patients.

Epidural Electrical Stimulation in Spinal Cord Injury