Baclofen pump treatment for people with dystonic cerebral palsy: a comparison of placebo and baclofe

Phase 1

Conditions: dytonic cerebral palsy
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
MedDRA version: 19.1Level: PTClassification code 10008129Term: Cerebral palsySystem Organ Class: 10010331 - Congenital, familial and genetic disorders

Registration Number: EUCTR2010-019768-35-NL

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Dystonic cerebral palsy
•GMFCS IV or V
•Lesions on MRI (cerebral white matter, basal ganglia, central cortex)
•Aged 4 to 25 years old
•Able and willing to complete study protocol
•Consensus about inclusion

Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Contra-indications for general anaesthesia
•Contra-indications for baclofen
•Inadequate knowledge of Dutch language
•Deep brain stimulation
•Ventriculoperitoneal drain

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of this study is to provide evidence for the effect of ITB treatment on the level of activities in dystonic CP patients. The primary outcome measurement is the effect on daily functioning and daily care measured by Goal Attainment Scaling. ;Secondary Objective: Secondary outcome measurements include dystonia, spinal muscle activity and spasticity. Side effects will be monitored and we will study whether patient characteristics influence outcome.;Primary end point(s): goal attainment scaling : attainment of individual goals;Timepoint(s) of evaluation of this end point: baseline, 3 months and 12 months

Secondary Outcome Measures