NCT07519915

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

Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a comprehensive framework to systematically investigate neuromodulation in this pediatric population. This integrative approach enables a direct link between mechanism, targeting, and clinical outcome.

Detailed description

Patients enrolled in the study will be receiving sacral neuromodulation (via surgical implantation) and MRIs prior to neuromodulation treatment and after 12 weeks. In cases of surgical implantation, the intraoperative testing is accompanied by a broad neuronal evaluation (The goal is to establish with these informations * improved understanding of interindividual sacral nerval anatomy * improved guidelines for implantation of sacral neuromodulation via 3D reconstructions (digital twins) * prediction of neural activation by sacral neuromodulation and improvement of response rates * mechanism guided implantation based on clinical symptoms (fecal incontinence vs. leading constipative symptoms) * improvement of therapeutic efficacy in comparison to non-guided implantation

Conditions

• Gastrointestinal Motility Disorders in Children
• Hirschsprung Disease
• Constipation - Functional

Interventions

Type	Name	Description
PROCEDURE	SNM/MRI/EMG	Participants are receiving clinical baseline evaluation, preoperative sacral and functional MRI, reconstruction of digital twin, surgical implantation of sacral neuromodulation including intraoperative testing, postoperative sacral and functional MRI, and clinical follow-up

Timeline

• Start date: 2018-07-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Germany