Dutch National ITB Study in Children With Cerebral Palsy

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine the efficacy and safety of treatment with intrathecal baclofen for severe spasticity in children with cerebral palsy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University
• Collaborator: Medtronic
• Treatments: Baclofen

Criteria

Inclusion Criteria:

• age between 4 and 16 years

• spastic diplegia or tetraplegia as part of CP

• insufficient response to oral spasticity-reducing medication

• in a mixed CP syndrome, spasticity has to be the most prominent sign

• spasticity results in a decrease in the quality of life of the child and/or its caregivers

• sufficient motivation for participation in the study including availability for follow-up

• magnetic resonance imaging of the brain rules out progressive causes of spasticity

Exclusion Criteria:

• hypersensitivity to baclofen

• contraindications for general anaesthesia

• insufficient general health

• intractable epileptic seizures

• infection of the lumbar skin

• a systemic infection