Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables
Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders
Friedrich-Alexander-Universität Erlangen-Nürnberg
25 participants
Jul 1, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- informed consent of patient and care taker
- gastrointestinal motility disorder, disregarding underlying diseases
- exclusion of mechanical obstructions in the gastrointestinal passage
- age between 3 and 18
Exclusion Criteria9
- pregnancy/breast feeding
- decreased renal or thyroidal function
- drug intake of Beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin
- contradictions for MRI
- indication for analgosedation for MRI
- inflammatory bowel diseases
- fractures/different anatomy in sacral region
- epilepsy
- presence of cardiac pacemakers
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07519915