Abstract
In children with spinal cord injury (SCI), scoliosis due to trunk muscle paralysis frequently requires surgical treatment. Transcutaneous spinal stimulation enables trunk stability in adults with SCI and may pose a non-invasive preventative therapeutic alternative. This non-randomized, non-blinded pilot clinical trial (NCT03975634) determined the safety and efficacy of transcutaneous spinal stimulation to enable upright sitting posture in 8 children with trunk control impairment due to acquired SCI using within-subject repeated measures study design. Primary safety and efficacy outcomes (pain, hemodynamics stability, skin irritation, trunk kinematics) and secondary outcomes (center of pressure displacement, compliance rate) were assessed within the pre-specified endpoints. One participant did not complete the study due to pain with stimulation on the first day. One episode of autonomic dysreflexia during stimulation was recorded. Following hemodynamic normalization, the participant completed the study. Overall, spinal stimulation was well-tolerated and enabled upright sitting posture in 7 out of the 8 participants.