RecruitingNAINTERVENTIONAL

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

This study is looking into sacral neuromodulation to help children who have tummy and bowel movement difficulties, including conditions like Hirschsprung disease and ongoing constipation. We want to understand how this treatment works better in children. By using advanced brain imaging (like special MRI scans), understanding how nerves work (electrophysiology), and creating detailed computer models, we hope to improve the treatment. The goal is to make sacral neuromodulation more effective, so children can have better bowel function and a better quality of life. We're trying to directly link how the treatment works, where it's placed, and the results it achieves.

At a glance

Status

Recruiting

Phase

Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Enrolment target

Start

01 Jul 2018

Estimated completion

31 Dec 2029

Gastrointestinal Motility Disorders in Children Hirschsprung Disease Constipation - Functional

What is this study about?

You might be reading this because your child experiences tummy or bowel problems, such as ongoing constipation or difficulties with how their gut muscles move food along. This study, called ‘SMART-GUT’, is focused on helping children aged 3 to 18 with these kinds of issues. We are particularly interested in a treatment called sacral neuromodulation.

Sacral neuromodulation is a treatment that involves sending gentle electrical signals to the nerves in the lower back (called sacral nerves) that control bowel and bladder function. For some children, these nerves don't work as they should, leading to problems. The main aim of this study is to learn more about how this treatment generally helps children, and how we can make it even better and more effective for each individual.

To do this, we're combining several advanced techniques. This includes special MRI scans to look at the brain and nerves, and other tests that help us understand how the electrical signals in nerves work. By putting all this information together, we hope to create clearer guides for doctors on how to place the neuromodulation device and predict who might benefit the most. Ultimately, we want to improve the success rates of this treatment and make sure children get the best possible help for their bowel problems.

Key takeaways

A study for children aged 3-18 with bowel movement disorders.
Investigating sacral neuromodulation, a treatment using gentle nerve signals.
Aims to improve treatment effectiveness using advanced scans and tests.
Involves a surgical implant and MRI scans before and after.
Seeking to create better guidelines for doctors on how to use the treatment.
Focuses on improving children's gut health and quality of life.

Who may be eligible?

This study is designed for children and young people aged between 3 and 18 years old. To be considered, they must have ongoing problems with their gut movements, such as constipation or other related difficulties. It's important that their bowel problems aren't caused by a physical blockage that needs surgery.

Before taking part, we would need consent (permission) from both the child (if old enough to understand) and their parent or guardian. We also need to make sure there are no other health conditions or medications that would make it unsafe for them to join the study or have specific scans, such as kidney or thyroid issues, certain heart conditions, epilepsy, or inflammatory bowel disease.

There are also specific reasons why a child might not be able to join, such as if they are pregnant or breastfeeding (though this is less common in this age group), or if they are taking certain medications like beta-blockers or strong painkillers. We also can't include children who have metal implants like pacemakers or certain bone fractures near the sacral area, as these can interfere with the MRI scans.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 3 and 18 years old?
Does your child have ongoing tummy or bowel movement problems?
Has a doctor confirmed there isn't a physical blockage causing the problems?
Is your child able to have an MRI scan (e.g., no metal implants)?
Is your child free from certain medical conditions (e.g., severe kidney/thyroid issues, epilepsy, inflammatory bowel disease)?
Is your child not currently taking certain medications (you'll get a full list)?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they would receive sacral neuromodulation, which involves a small surgical procedure to implant a device. Before this procedure, and again about 12 weeks after, they would have special MRI scans. During the surgery, extra tests will be done to understand how their nerves respond, which helps us learn more about individual nerve structures. The long-term follow-up to see how the treatment is working would be part of their ongoing medical care. The specific number of visits and exact duration would be discussed in detail by the study team.

Potential risks and benefits

Taking part in this study offers the potential benefit of a treatment designed to improve your child's bowel function and quality of life. This research also helps us learn more to improve future care for other children. However, as with any medical procedure, there are potential risks associated with surgery and the advanced scans, which will be fully explained to you. You are free to withdraw your child from the study at any time without affecting their standard medical care.

Locations (1)

Pediatric Surgery in the Children's Hospital
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What is sacral neuromodulation?

It's a treatment where a small device sends gentle electrical signals to nerves in the lower back to help control bowel and bladder function.

What are 'gastrointestinal motility disorders'?

These are problems where the muscles of the gut don't move food and waste along properly, leading to issues like constipation or irregular bowel movements.

Will my child have surgery?

Yes, if your child is included, they would have a small surgical procedure to implant the neuromodulation device.

What's an MRI scan?

It's a powerful and safe scan that uses magnets and radio waves to create detailed pictures inside the body, in this case, of the brain and nerves.

Who is running this study?

This study is part of the 'SMART-GUT project', and the specific team involved will be able to give you more details.

How to find out more

Sonja Diez, PD Dr. med.

sonja.diez@uk-erlangen.de 09131 - 85 32923 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.