Not yet recruitingPhase 4
Comparison of two treatments (intrathecal baclofen pump and selective dorsal rhizotomy) for children with cerebral palsy who cannot walk
Key facts
- Who runs it
- UZ Leuven
- Where
- Belgium and Netherlands7 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 48 people, planned
- Started
- 1 Jan 2026
- Expected to end
- 30 Apr 2039
- Type of study
- Interventional
- Record updated
- 3 April 2026
Who can take part
- Age
- Up to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Participants eligible for inclusion in this Trial must meet all of the following criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. Informed assent has been obtained by the child in a manner that is appropriate for their age and understanding. 2. Male or female patients 3. Aged ≥ 4 and <18 years 4. With spastic CP 5. Gross motor function classification system (GFMCS) grade 4 or 5 6. Spasticity insufficiently controlled with conservative therapy and/or oral baclofen or intolerable side effects. Patients are allowed to continue or change their usual medication during the study. We will register concomitant medication throughout the study so we can evaluate whether this can be reduced over time. Cross-over neurosurgical procedures (ITB after SDR, or SDR after ITB) are not allowed during the first year in order to not influence the impact of our techniques. Orthopedic interventions and/or botulinum to
Who cannot take part
- Participants eligible for this Trial must not meet any of the following criteria: 1. Dystonia 2. Basal ganglia/thalamus lesions or normal brain MRI 3. <15kg body weight 4. Previous ITB/SDR surgery 5. Evidence of genetic illness 6. Evidence of neurological progressive illness
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
To compare the health-related quality of life, safety profile and cost effectiveness and cost utility 1 year after SDR and ITB in non-ambulatory children with spastic Cerebral palsy.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Intrathecal baclofen pump versus selective dorsal rhizotomy for non-ambulatory children with cerebral palsy
- Record updated
- 3 April 2026