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

RecruitingNAAges 3 Years - 18 YearsAllFriedrich-Alexander-Universität Erlangen-Nürnberg
NCT07519915 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • SNM/MRI/EMG
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Where

1 site
Pediatric Surgery in the Children's Hospital
Erlangen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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