Sacral nerve stimulation for children with bowel motility problems
Official title: Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders
Run by Friedrich-Alexander-Universität Erlangen-Nürnberg · NCT07519915 · Data updated 2026-11-12
This project tests sacral neuromodulation in children aged 3–18 with gastrointestinal motility disorders to see if imaging-guided, personalized implantation improves symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Friedrich-Alexander-Universität Erlangen-Nürnberg Academic / other |
| Locations | 1 site (Erlangen) |
| Status | Recruiting |
| Started | July 1, 2018 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | April 9, 2026 |
| Trial ID | NCT07519915 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3–18 with gastrointestinal motility disorders (including chronic functional constipation or Hirschsprung disease), no mechanical bowel obstruction, and who are candidates for sacral neuromodulation and MRI are ideal.
✕Probably not a fit
Patients with inflammatory bowel disease, epilepsy, MRI contraindications, cardiac pacemakers, significant sacral anatomical abnormalities, or taking excluded medications are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children who are receiving surgical sacral neuromodulation will have MRI scans before treatment and again after 12 weeks, alongside intraoperative electrophysiological testing. Researchers will create patient-specific 3D reconstructions and biophysical models to predict nerve activation and guide lead placement. Clinical outcomes will be linked to imaging and modeling results to identify mechanisms and optimize targeting for fecal incontinence versus constipative symptoms. The goal is to produce implantation guidelines and improve response rates by tailoring therapy to each child’s sacral anatomy and physiology.
Why it matters
Potential benefit: If successful, this approach could increase the chance that children benefit from sacral neuromodulation by improving lead placement and overall therapy effectiveness.
How similar studies have gone: Sacral neuromodulation has established benefits in adults and small pediatric case series, but systematic imaging- and mechanism-guided approaches in children remain novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Pediatric Surgery in the Children's Hospital
Erlangen, Germany Recruiting
Study contacts
- Study coordinator: Sonja Diez, PD Dr. med.
- Email: sonja.diez@uk-erlangen.de
- Phone: 09131 - 85 32923
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.