Sacral nerve stimulation for children with bowel motility problems
Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Friedrich-Alexander-Universität Erlangen-Nürnberg Academic / other |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT07519915 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Sacral neuromodulation has established benefits in adults and small pediatric case series, but systematic imaging- and mechanism-guided approaches in children remain novel.
Eligibility criteria
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 this trial is running
Erlangen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.