Actively Recruiting
Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders
Led by Friedrich-Alexander-Universität Erlangen-Nürnberg · Updated on 2026-04-09
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of sacral neuromodulation in children aged 3 to 18 with gastrointestinal motility disorders, including Hirschsprung disease and functional constipation. The study aims to improve understanding of how this therapy works by combining advanced brain and nerve imaging, patient-specific modeling, and clinical evaluations. The goal is to link how the neuromodulation targets nerves with patient outcomes. Participants will undergo surgical implantation of sacral neuromodulation, guided either by a personalized digital twin model and intraoperative testing or by general adult-based implantation guidelines. Before surgery, patients will have sacral and functional MRIs, and these imaging studies will be repeated 12 weeks after treatment. Intraoperative neuronal evaluations accompany the implantation to improve implantation accuracy and predict treatment response. During the study, participants will receive clinical baseline assessments and follow-up evaluations. Researchers will track outcomes such as fecal incontinence, abdominal pain, defecation frequency, urinary incontinence, and proprioception within 12 weeks of neuromodulation. This comprehensive approach involves imaging, clinical testing, and monitoring to learn about therapy effects and improve treatment strategies for pediatric gastrointestinal motility disorders.
CONDITIONS
Brief Title
Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent of patient and care taker
- Diagnosis of gastrointestinal motility disorder regardless of underlying diseases
- No mechanical obstructions in the gastrointestinal passage
- Age between 3 and 18 years
You will not qualify if you...
- Pregnancy or breastfeeding
- Decreased kidney or thyroid function
- Use of certain drugs including beta-blockers, antispasmodics, haloperidol, heroin, and others listed
- Contraindications for MRI
- Need for sedation during MRI
- Inflammatory bowel diseases
- Fractures or abnormal anatomy in the sacral region
- Epilepsy
- Presence of cardiac pacemakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive surgical implantation of sacral neuromodulation including intraoperative testing and a broad neuronal evaluation.
1 surgical implantation visit (in-person)
Duration - 12 weeks
Participants undergo sacral neuromodulation treatment guided by digital twin reconstructions or general knowledge.
MRI scans before treatment and after 12 weeks; clinical evaluations during treatment
Duration - Up to 12 weeks post-implantation
Participants receive clinical follow-up including postoperative sacral and functional MRI assessments.
Approximately 2 post-operative visits including MRI assessments
Trial Site Locations
Total: 1 location
1
Pediatric Surgery in the Children's Hospital
Erlangen, Germany, 91054
Actively Recruiting
Research Team
S
Sonja Diez, PD Dr. med.
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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