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How children with dystonic cerebral palsy respond to baclofen, rhizotomy or DBS

Tracks baclofen, rhizotomy, or DBS in children with dystonic cerebral palsy.

Key facts

Who runs it
Baylor College of Medicine
Where
Houston, United StatesSee the site
Trial code
Registry title
Intrathecal Baclofen and Pediatric Dystonia
Status
Recruiting
People taking part
65 people, planned
Started
1 Nov 2024
Expected to end
31 Aug 2029
Type of study
Interventional, 3 groups
Treatments tested
  • ITB Titration Protocol
  • Ventral Dorsal Rhizotomy
  • Deep Brain Stimulation
  • Research Assessments and Study Monitoring
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young people with dystonic cerebral palsy who get intrathecal baclofen (ITB), ventral dorsal rhizotomy (VDR) or deep brain stimulation (DBS) as part of usual care. The study follows how they do.

Age
Less than 21 years of age. For a new ITB pump, the child must be large enough for the pump (typically ~18 kg/4 years old).
Sex
All sexes can join.
Disease stage
A diagnosis of cerebral palsy (CP). For ITB and VDR groups, dystonia (involuntary muscle tightening) confirmed with the Hypertonia Assessment Tool (HAT). For ITB groups, a Barry-Albright Dystonia Scale (BADS) score >14.
Earlier treatment
A doctor must have chosen the child for ITB, VDR or DBS, and the family has agreed. Children who already have an ITB pump can join if it was put in less than 12 months ago. An ITB trial dose is not needed.

Main reasons for not taking part

  • Urgent need for ITB, such as status dystonicus or paroxysmal sympathetic hyperactivity
  • Botulinum injections within 3 months or phenol injections within 6 months
  • Living in foster care or in prison
  • Family not willing to take part in the schedule of assessments

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • Child must be large enough to have an ITB pump implanted (typically ~18 kg/4 years old)
  • Child must be less than 21 years of age
  • 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 >14
  • 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
  • Child must be less than 21 years of age
  • 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 >14
  • Currently less than 12 months post ITB pump implant for tone management
  • Child and family are willing to participate in the 12-month outcome measure assessment
  • Child must be less than 21 years of age
  • They have a diagnosis of CP
  • Presence of dystonia verified with a documented Hypertonia Assessment Tool (HAT)
  • They have been identified by a physician as a candidate for VDR for tone management and the family/child have agreed to proceed with surgery
  • Child must be less than 21 years of age
  • They have a diagnosis of CP and have been identified by a physician as a candidate for DBS

Who cannot take part

  • Emergent need for ITB such as status dystonicus or paroxysmal sympathetic hyperactivity
  • Botulinum injections within 3 months or phenol injections within 6 months
  • Foster care placement or incarceration
  • Family not willing to participate in schedule of assessments

Where in United States

  • Texas Childrens HospitalHouston, United StatesContact: Principal Investigator, MD, PhDTaking people

About the trial

What the trial wants to find out

The goal of this study is to better understand outcomes in children with dystonic cerebral palsy (CP) receiving intrathecal baclofen (ITB), ventral dorsal rhizotomy (VDR), or deep brain stimulation (DBS) as part of standard clinical care. The decision to proceed with ITB, VDR, or DBS is made independently of research participation.

Read full original descriptionShow less

The study aims to:

1. Evaluate changes in dystonia and other clinically important outcomes; 2. Identify characteristics associated with treatment response; and 3. Develop a multidimensional outcome measure for children with dystonic CP.

Participants receiving ITB will follow a study-specific standardized titration protocol designed to identify a dose that provides maximum benefit with minimal side effects. Participants in all three groups will complete research assessments and questionnaires at protocol-specified timepoints to evaluate dystonia, spasticity, function, pain, stress, and quality of life.

The 3 groups in the trial

  • Intrathecal BaclofenTreatment being tested

    Participants in this arm receive intrathecal baclofen (ITB) as part of standard clinical care. The decision to proceed with ITB is made independently of research participation. Enrolled participants follow a study-specific ITB titration protocol and complete research assessments and study monitoring at protocol-specified timepoints.

    Treatment: ITB Titration Protocol and Research Assessments and Study Monitoring

  • Ventral Dorsal RhizotomyOther group

    Participants in this arm undergo ventral dorsal rhizotomy (VDR) as part of standard clinical care. The decision to proceed with VDR is made independently of research participation. The study does not assign participants to VDR or modify the VDR procedure or clinical follow-up. Enrolled participants complete research assessments and study monitoring at baseline and 3, 6, and 12 months.

    Treatment: Ventral Dorsal Rhizotomy and Research Assessments and Study Monitoring

  • Deep Brian StimulationOther group

    Participants in this arm undergo deep brain stimulation (DBS) as part of standard clinical care. The decision to proceed with DBS is made independently of research participation. The study does not assign participants to DBS or modify the DBS procedure or clinical follow-up. Enrolled participants complete research assessments and study monitoring at baseline and 3, 6, and 12 months.

    Treatment: Deep Brain Stimulation and Research Assessments and Study Monitoring

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Predicting Response In Children With Dystonic Cerebral Palsy to Intrathecal Baclofen (Predict-ITB), Ventral Dorsal Rhizotomy (Predict-VDR), and Deep Brain Stimulation (Predict-DBS)
Plain-language title
How children with dystonic cerebral palsy respond to baclofen, rhizotomy or DBSGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Publications
Record updated
5 November 2026