Actively Recruiting

Phase Not Applicable
Age: 3Years - 18Years
All Genders
NCT07519915

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

Led by Friedrich-Alexander-Universität Erlangen-Nürnberg · Updated on 2026-04-09

25

Participants Needed

1

Research Sites

600 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Informed consent from patient and caregiver
  • Diagnosis of gastrointestinal motility disorder regardless of underlying disease
  • No mechanical obstruction in gastrointestinal tract
  • Age between 3 and 18 years
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Reduced kidney or thyroid function
  • Use of certain drugs including beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin
  • MRI contraindications
  • Need for sedation for MRI
  • Inflammatory bowel diseases
  • Fractures or anatomical abnormalities in sacral area
  • Epilepsy
  • Presence of cardiac pacemakers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
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Trial Site Locations

Total: 1 location

1

Pediatric Surgery in the Children's Hospital

Erlangen, Germany, 91054

Actively Recruiting

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Research Team

S

Sonja Diez, PD Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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