Effect of Cervical Epidural STimulation After Neurological Damage: protocol for phase I/II open label controlled CE-STAND trial

Introduction Spinal cord injury (SCI) affects over 18 000 individuals annually, leading to significant motor and autonomic dysfunctions that reduce quality of life (QoL). Epidural spinal cord stimulation (eSCS) has shown potential in restoring function in chronic individuals with SCI. However, research on cervical and autonomic dysfunction-related SCI remains limited. This study will assess the safety and efficacy of eSCS in improving autonomic and volitional functions, as well as truncal stability, bowel, bladder and sexual function, and overall QoL. Methods The study is a phase I/II trial in which participants will serve as their own controls. The Abbott Eterna epidural stimulator system will be implanted, and assessments will occur every 3 months. The study will be conducted over a period of 4 years. A total of 36 participants will be enrolled and followed for 1 year. Analysis Bayesian optimisation will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit. Ethics and dissemination Food and Drug Administration and University of Minnesota Institutional Review Board approvals have been secured for the study. Interim reports will be made available through peer-reviewed journals, conference presentations and clinical network reporting. Conclusion CE-STAND (Cervical Epidural STimulation After Neurological Damage) seeks to advance SCI treatment by expanding eSCS applications in chronic cervical SCI, improving patient outcomes and reducing healthcare costs. Future studies could consider a larger sample size, long-term safety, matched-control and randomisation. Trial registration number NCT06410001