Effect of Cervical Epidural STimulation After Neurological Damage: protocol for phase I/II open label controlled CE-STAND trial
Year: 2026
Type: article
Study design: Study Protocol
Abstract: 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 three months. The study will be conducted over a period of four years. A total of 36 participants will be enrolled and followed for one year. Analysis Bayesian Optimization will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit. Ethics and dissemination FDA and UMN IRB 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 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 randomization. Registration The study is registered on ClinicalTrials.gov ( NCT06410001 ). Strengths and Limitations Strengths This trial investigates eSCS for improvement of autonomic and volitional function in individuals with SCI, an important missing link in the treatment of SCI. A key innovation is the incorporation of microneurography, the gold standard test used to quantify muscle sympathetic nerve activity (MSNA), which is underinvestigated in SCI neuromodulation research. Furthermore, the trial enrolls cervical individuals with SCI, a population that has previously been underrepresented in this research area. The research design is sound, with well-defined outcomes aimed at maximizing methodological quality and regulatory compliance while minimizing bias. The provision of an interim analysis allows for early review of findings, enabling protocol modifications and resolution of study issues, while also guiding future research. Limitations A main shortcoming of this trial is the extremely small number of subjects, which can lower statistical power and limit generalizability of the results. The study improves the representativeness of individuals with cervical SCI. However, it does not consider variability in injury levels, which can limit the generalizability of findings. The trial follows up participants over one year, measuring short-term effects, but not tracking the long-term safety and efficacy of the intervention. A second challenge is the variability of subjects in response to stimulation, which can lead to variability in optimization of parameters and treatment outcomes. Since there is no treatment for chronic SCI, participants will serve as their own controls which could challenge blinding of participants.
Source: BMJ Open
Institution: University of Minnesota
Language: English
Topic: Spinal Cord Injury Research
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
OpenAlex ID: W7128821605