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Comparison of two treatments (intrathecal baclofen pump and selective dorsal rhizotomy) for children with cerebral palsy who cannot walk
EU CTIS ID: 2024-518822-33-01
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.