Objectives: 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.
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters:
The primary outcome measurement is the effect on daily functioning and daily
care measured by Goal Attainment Scaling.
Secondary outcome
Secondary outcome measurements include dystonia, spinal muscle activity and
spasticity. Side effects will be monitored and we will study whether patient
characteristics influence outcome.
Background summary
Dyskinetic cerebral palsy (CP) is mostly caused by damage to the basal ganglia
and central cortex. Due to the dystonic movements the daily care of these
patients can be difficult. Intrathecal baclofen ITB treatment has been
suggested as a potential treatment for dystonia but the effects on daily
activities are unknown and prospective data are needed to judge the usefulness
of ITB in dystonic cerebral palsy.
Study objective
Objectives: 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.
Study design
Study design: double blind placebo-controlled randomized clinical trial.
Intervention
Intervention: Group A will receive three months of continuous ITB treatment and
group B will receive three months placebo treatment, both via an implanted
pump.
Study burden and risks
We feel the risk and burden of participating in this study are relatively low.
No extra risks are involved for subjects in the ITB treatment group. However,
possibly higher risk for common complications occur for the subjects randomized
to the placebo group.
Postbus 7057
Amsterdam 1007 MB
NL
Postbus 7057
Amsterdam 1007 MB
NL
Listed location countries
Age
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
Exclusion criteria
-Contra-indications for general anaesthesia
-Contra-indications for baclofen
-Inadequate knowledge of Dutch language
-Deep brain stimulation
-Ventriculoperitoneal drain
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019768-35-NL |
| CCMO | NL33312.029.10 |
| OMON | NL-OMON21127 |