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Recruiting NCT07519915

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

No phase Interventional Gastrointestinal Motility Disorders in Children Hirschsprung Disease Constipation - Functional

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SNM/MRI/EMG.
Who it may be relevant to
Registry conditions: Gastrointestinal Motility Disorders in Children, Hirschsprung Disease, Constipation - Functional. Basic parameters: 3 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders

Overview

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.

Detailed description

Patients enrolled in the study will be receiving sacral neuromodulation (via surgical implantation) and MRIs prior to neuromodulation treatment and after 12 weeks. In cases of surgical implantation, the intraoperative testing is accompanied by a broad neuronal evaluation (The goal is to establish with these informations

* improved understanding of interindividual sacral nerval anatomy * improved guidelines for implantation of sacral neuromodulation via 3D reconstructions (digital twins) * prediction of neural activation by sacral neuromodulation and improvement of response rates * mechanism guided implantation based on clinical symptoms (fecal incontinence vs. leading constipative symptoms) * improvement of therapeutic efficacy in comparison to non-guided implantation

Interventions

  • Procedure SNM/MRI/EMG
    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

Primary outcome measures

  • Fecal incontinence [Time frame: Within 12 weeks of sacral neuromodulation]
  • Abdominal pain [Time frame: Within 12 weeks of sacral neuromodulation]
  • Defecation frequency [Time frame: Within 12 weeks of sacral neuromodulation]
  • Urinary incontinence [Time frame: Within 12 weeks of sacral neuromodulation]
  • Proprioception [Time frame: Within 12 weeks of sacral neuromodulation]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Pediatric Surgery in the Children's Hospital — Erlangen

Identifiers

NCT: NCT07519915 · SMART-GUT_V1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗