Understanding and Improving Sacral Neuromodulation Treatment in Children with Gastrointestinal Motility Disorders

What this Trial Is About

Researchers are studying the effects of sacral neuromodulation in children aged 3 to 18 with gastrointestinal motility disorders, including Hirschsprung disease and functional constipation. The study aims to improve understanding of how this therapy works by combining advanced brain and nerve imaging, patient-specific modeling, and clinical evaluations. The goal is to link how the neuromodulation targets nerves with patient outcomes. Participants will undergo surgical implantation of sacral neuromodulation, guided either by a personalized digital twin model and intraoperative testing or by general adult-based implantation guidelines. Before surgery, patients will have sacral and functional MRIs, and these imaging studies will be repeated 12 weeks after treatment. Intraoperative neuronal evaluations accompany the implantation to improve implantation accuracy and predict treatment response. During the study, participants will receive clinical baseline assessments and follow-up evaluations. Researchers will track outcomes such as fecal incontinence, abdominal pain, defecation frequency, urinary incontinence, and proprioception within 12 weeks of neuromodulation. This comprehensive approach involves imaging, clinical testing, and monitoring to learn about therapy effects and improve treatment strategies for pediatric gastrointestinal motility disorders.

Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables