AuthorisedTherapeutic use (Phase IV)Interventional

Intrathecal baclofen pump versus selective dorsal rhizotomy for non-ambulatory children with cerebral palsy

This research study is looking at two different treatments for children with cerebral palsy who are not able to walk. These treatments aim to help with muscle stiffness. One treatment involves a small pump that delivers a medicine called baclofen into the fluid surrounding the spinal cord. The other is a surgery called selective dorsal rhizotomy. The main goal is to see which treatment best improves the child's care and daily life over the first year after the treatment. Researchers will also look at side effects, how well the treatments work, and how they affect things like movement, sleep, and overall quality of life for the child and their family.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

UZ Leuven

Enrolment target

Start

27 Jan 2026

Cerebral Palsy

What is this study about?

This study is designed to compare two established treatments for children with cerebral palsy who find walking difficult or impossible. Cerebral palsy can cause muscles to be very stiff, which specialists call spasticity. This stiffness can make daily activities challenging for both the child and their caregivers.

The first treatment involves a medication called baclofen, delivered directly to the spinal cord through a small, implantable pump. This helps to relax the stiff muscles. The second treatment is a specific type of surgery called selective dorsal rhizotomy. During this surgery, certain nerves in the spinal cord that contribute to muscle stiffness are carefully cut.

The main aim of this research is to understand which of these two approaches leads to better improvements in a child's care and daily life, as reported by their caregivers, within the first year after the treatment. The study is also looking into other important aspects, such as side effects, the cost-effectiveness of each treatment, and how they impact various parts of a child's health and well-being, including their movement, sleep patterns, and overall quality of life.

Key takeaways

A study comparing two treatments for muscle stiffness in cerebral palsy.
It's for children unable to walk.
Compares a baclofen pump versus a special surgery (SDR).
Focuses on how daily care improves, reported by caregivers.
Also looks at side effects, movement, and quality of life.
Participation lasts for one year after treatment.

Who may be eligible?

This study is open to all children, regardless of their age or gender, who have cerebral palsy and are not able to walk. The researchers want to include a wide range of children to understand how well these treatments work for different individuals.

There aren't specific age limits mentioned, meaning that children from very young to older may be able to take part. Similarly, both boys and girls are welcome to be considered for the study.

However, it's important to remember that detailed medical criteria will need to be met to ensure the child is suitable for either treatment and for the study itself. A doctor or research team would discuss these specific requirements with you.

Quick self-check

Does your child have cerebral palsy?
Is your child currently not able to walk?
Are you a caregiver willing to provide information about your child's daily care?
Are you able to attend appointments for assessments over a year?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, they would either receive a baclofen pump or undergo selective dorsal rhizotomy surgery. Before and after the treatment, there would be several assessments. These assessments would involve you, as the caregiver, answering questions about your child's care and daily life using a special questionnaire. We would also gather information on many aspects of your child's health, such as their muscle stiffness, movement, sleep, and overall quality of life.

These assessments would happen immediately before the treatment and then again at various points during the first year after the treatment. The total duration of active participation in the study is one year, focusing on the changes measured immediately after treatment and in the following 12 months.

Potential risks and benefits

Taking part in this study could potentially offer your child a chance for improved muscle stiffness and better daily care, as both treatments are designed to help with symptoms of cerebral palsy. However, like all medical treatments and surgeries, there are potential risks, including side effects from medication or complications related to surgery. The study aims to gather more information on these aspects. You have the right to withdraw your child from the study at any time, for any reason, without affecting their future medical care.

Locations (2)

—
Netherlands
—
Belgium

Common questions

What is cerebral palsy?

Cerebral palsy is a group of conditions that affect movement and muscle tone or posture. It's caused by damage to the developing brain, most often before birth.

What is baclofen?

Baclofen is a medicine that helps to relax stiff muscles. In this study, it's delivered directly to the spinal cord with a special pump.

What is selective dorsal rhizotomy (SDR)?

SDR is a type of surgery performed on the nerves in the spinal cord to reduce severe muscle stiffness (spasticity).

Will my child have to start walking if they join the study?

No, this study is specifically for children who are not able to walk. The treatments aim to reduce stiffness and improve daily care, not necessarily to enable walking.

How long will the study last for my child?

Your child's involvement in the study will focus on the first year after their treatment, with assessments happening before and during that year.