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Intrathecal Baclofen and Pediatric Dystonia

RecruitingNAAges any - 17 YearsAllBaylor College of Medicine
NCT06606574 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 dyston

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Titration protocol
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Where

1 site
Texas Childrens Hospital
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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