Pilot Study of Non-invasive Spinal Cord Stimulation to Improve Autonomic Functions After Spinal Cord Injury

What this Trial Is About

Researchers are studying the use of transcutaneous spinal cord stimulation TCSCS to improve autonomic functions that affect quality of life in people with spinal cord injury SCI. This pilot clinical trial focuses on key autonomic problems like blood pressure regulation, bladder, bowel, and sexual dysfunction in adults with chronic SCI at or above the T6 spinal segment. The study is designed to explore how TCSCS may help reduce these dysfunctions and improve daily living. Participants will be randomly assigned to receive TCSCS using a non-invasive device TESCoN or SCONE targeting either the midlow thoracic or lumbosacral spinal cord levels. The treatment lasts for 8 weeks with sessions three times per week. Before treatment, participants undergo mapping of spinal cord segments and baseline functional assessments with and without stimulation. After the 8-week treatment, further assessments are conducted over 4 weeks, and then repeated 8 weeks after stopping therapy to evaluate lasting effects. Throughout approximately 42 visits, participants will undergo various evaluations including blood pressure monitoring during tests such as head up tilt, digital anorectal stimulation, and urodynamic investigations. Additional tests include anorectal manometry, colonic motility assessment, cerebral blood flow measurements, and cognitive performance during stimulation. Researchers will track changes in these measures to assess TCSCS effects on autonomic functions and safety over time.

Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury