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

Completed

• Conditions: cerebral palsy; 10010335

• Registration Number: NL-OMON45097
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-03-26
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 41

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters:<br /><br>The primary outcome measurement is the effect on daily functioning and daily<br /><br>care measured by Goal Attainment Scaling. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measurements include dystonia, spinal muscle activity and<br /><br>spasticity. Side effects will be monitored and we will study whether patient<br /><br>characteristics influence outcome.</p><br>