Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury.

Details

Project Title: Transcutaneous Electrical Spinal Cord Stimulation During Assisted Cycling Training for Incomplete Spinal Cord Injury. A Randomized Double-Blind Study. Sponsor: Hospital Sant Joan de Déu Palma-Inca Principal Investigator: Luis Garcés Pérez, MD. Attending Physician. Department of Rehabilitation. Hospital Sant Joan de Déu Palma-Inca Study Site(s): Hospital Sant Joan de Déu Palma-Inca Study Design: Randomized, double-blind, sham-controlled clinical trial Condition or Disease Under Study: Spinal cord injury Primary and Secondary Objectives: The primary objective is to evaluate the effectiveness of transcutaneous spinal cord stimulation in improving lower limb motor function when used in combination with assisted cycling training. Secondary objectives are to assess whether it has an effect on the frequency of muscle spasms and on bladder or bowel function. Primary Outcome Measure: Lower Extremity Motor Score (LEMS) of the ASIA Impairment Scale for spinal cord injury. Study Population and Total Number of Subjects: Individuals with incomplete spinal cord injury (ASIA B, C, or D) with less than 12 months since injury. A total of 40 subjects will be required for the study.