Comparison of two treatments (intrathecal baclofen pump and selective dorsal rhizotomy) for children with cerebral palsy who cannot walk

Ki vehet részt

• 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

Ki nem vehet részt

• 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