Actively Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Led by Baylor College of Medicine · Updated on 2025-07-30
65
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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) Determine if ITB reduces dystonia while identifying other potential benefits, (2) Identify the characteristics of children with the best response to ITB (3) Develop a holistically representative composite outcome measure for dystonic CP. This study will evaluate patient improvement by using a standardized titration, or medication management, protocol to gradually increase the childs ITB dosages over a 12-month period until they achieve maximum benefit with minimal to no side effects. This titration protocol mimics what is currently done through routine care but with more precision. This study will also directly measure the global effects of ITB, taking into account spasticity, known dystonia triggers (e.g. pain), and patterns of CNS injury that cause dystonia. Participants will: 1. Complete a total of 4 additional clinic visits outside usual care. These appointments will be with physical and occupational therapists as well as the study PI to complete evaluations for dystonia, spasticity, and function. 2. Complete several questionnaires at these visits. The total duration of the study for an individual child will be 12 months.
CONDITIONS
Official Title
Intrathecal Baclofen and Pediatric Dystonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child must be large enough to have an ITB pump implanted (typically around 18 kg or 4 years old)
- Diagnosis of cerebral palsy
- Presence of dystonia verified by Hypertonia Assessment Tool and a Barry-Albright Dystonia Scale (BADS) score greater than 15
- Identified by a physician for ITB treatment and family/child agreed to proceed with implantation
- Willingness to participate in all scheduled assessments before and after implantation, including biweekly visits until ideal dosing is reached and follow-ups
You will not qualify if you...
- Urgent need for ITB, such as status dystonicus or paroxysmal sympathetic hyperactivity
- Botulinum toxin injections within 3 months or phenol injections within 6 months before enrollment
- Placement in foster care or incarceration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Texas Childrens Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sruthi Thomas, MD, PhD
CONTACT
R
Rachel Arp
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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