Status:
RECRUITING
Intrathecal Baclofen and Pediatric Dystonia
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Dystonic Cerebral Palsy
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to better understand the effects of intrathecal baclofen (ITB) on children with dystonic cerebral palsy (CP). The main questions this study aims to answer are: (1)...
Detailed Description
Cerebral palsy (CP) is the most common cause of physical disability in childhood and affects \~1 in 323 in the US per the CDC. The lifetime medical costs for an individual with CP was expected to be \...
Eligibility Criteria
Inclusion
- Child must be large enough to have an ITB pump implanted (typically \~18 kg/4 years old)
- They have a diagnosis of CP
- Presence of dystonia verified with a documented Hypertonia Assessment Tool (HAT) and they must have a Barry-Albright Dystonia Scale (BADS) score \>15
- They have been identified by a physician for ITB treatment for tone management and the family/child have agreed to proceed with implantation; note: an ITB trial dose is not necessary to qualify
- Child and family are willing to participate in full schedule of formal assessments, spanning pre-implantation, every 2 weeks until ideal intrathecal baclofen pump dosing is reached, and follow-up assessments
Exclusion
- Emergent need for ITB such as status dystonicus or paroxysmal sympathetic hyperactivity
- Botulinum injections within 3 months or phenol injections within 6 months of enrollment
- Foster care placement or incarceration
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06606574
Start Date
November 1 2024
End Date
August 31 2029
Last Update
July 30 2025
Active Locations (1)
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1
Texas Childrens Hospital
Houston, Texas, United States, 77030