Intrathecal Baclofen and Pediatric Dystonia

Recruiting now · Not applicable

Conditions studied: Dystonic Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT06606574

Run by

Baylor College of Medicine

People needed

65

Starts

2024-11-01

Expected to finish

2029-08-31

Last updated by the study team

2025-07-30

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Texas Childrens Hospital — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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