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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
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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