Dutch National ITB Study in Children With Cerebral Palsy

Maastricht University

Status and phase

Completed

Phase 3

Conditions

Spasticity

Cerebral Palsy

Treatments

Device: infusion pump for intrathecal baclofen, Synchromed, Medtronic

Drug: baclofen, intrathecal

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00367068

PF-147

Details and patient eligibility

About

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.

Full description

Spasticity in cerebral palsy (CP) is a serious problem leading to pain, sleep disturbance, increased expenditure of energy and/or interference with positioning, transfers, dressing and body hygiene. In later stages, secondary phenomena, such as contractures, decubitus and heterotopic calcifications of joints or tendons may create large treatment problems. A substantial group of children with severe CP does not respond to regular treatments, such as physical therapy, orthopaedic surgery or oral medication. An effective treatment option for intractable spasticity is the continuous delivery of intrathecal baclofen (CITB). In 2000, the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) published a systematic review on the body of evidence about intrathecal baclofen (ITB) for spasticity in individuals with CP. It appeared that only a small and uncertain number of children had been studied. Except for two case-reports, none of the studies solely concerned children. The research methodology employed in three quarters of the available studies was not capable of confirming treatment effect. The AACPDM underlined the need for further high-level research in the form of prospective, randomized trials that use valid and reliable outcome measures in well described and homogeneous groups.

In 1998 the Dutch Study Group on Child Spasticity designed the Dutch national study on the effectiveness and safety of ITB for refractory spasticity in children with cerebral palsy. The Dutch national ITB study included four phases: 1] the selection phase, 2] the double-blind, placebo-controlled dose-escalation test treatment phase, 3] the prospective, randomized, open-label implantation phase and 4] the follow-up phase.

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

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