Pilot Study on Safety and Feasibility of Transcutaneous Spinal Cord Stimulation for Traumatic and Non-Traumatic Spinal Cord Injuries

What this Trial Is About

Researchers are evaluating the safety and feasibility of transcutaneous spinal cord stimulation Tc-SCS in patients with spinal cord injury SCI, both traumatic tSCI and non-traumatic ntSCI, including those with degenerative cervical myelopathy DCM. This pilot study aims to include 30 patients divided into three groups those with non-traumatic SCI undergoing or offered surgery, early traumatic SCI patients screened during hospital admission, and delayed traumatic SCI patients screened 6 to 24 months after injury. The study focuses on stimulating the injured spinal cord and recording autonomic and sensorimotor functions across these groups. The intervention uses a device that delivers bursts of electrical stimulation through the skin at specific frequencies and intensities to activate muscles in the upper and lower limbs. Participants receive Tc-SCS at intervals during their admission, rehabilitation, and clinical follow-up. The study compares outcomes across the three groups, including a control group of chronic tSCI patients receiving the stimulation later after injury. Participants will undergo multiple assessments including neurological classifications, motor function tests, blood pressure monitoring, and quality of life questionnaires over a 12-month period. Researchers will monitor safety, adherence to the protocol, and collect data on adverse events. The outcomes will help determine the potential clinical utility of Tc-SCS and inform future studies on improving paralysis, autonomic dysfunction, and pain in SCI patients.

Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study