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Intrathecal Baclofen and Pediatric Dystonia
PREDICT-ITB: Predicting Response in Children With Dystonic Cerebral Palsy to Intrathecal Baclofen
Who can join
Up to age 17 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Titration protocol (other)
Sponsor: Baylor College of Medicine · Participants: 65 · Started: Nov 1, 2024
Contact the study team
- Sruthi Thomas, MD, PhD · Phone: 832-824-4945
- Rachel Arp · Phone: (936) 267-7707
Official record on ClinicalTrials.gov — NCT06606574
Locations in the U.S.
| Texas | Texas Childrens Hospital, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.