Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial

Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial - ITB in dystonic CP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45097

Enrollment

Registered

2012-04-05

Start date

2013-01-22

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral palsy

Interventions

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.

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main study parameters: The primary outcome measurement is the effect on daily functioning and daily care measured by Goal Attainment Scaling.	—

Secondary

Measure	Time frame
Secondary outcome measurements include dystonia, spinal muscle activity and spasticity. Side effects will be monitored and we will study whether patient characteristics influence outcome.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)