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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorFriedrich-Alexander-Universität Erlangen-Nürnberg

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SNM/MRI/EMG

Treatment groups

25 Participants
are divided into 2 treatment groups