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Intrathecal Baclofen for Dystonic Cerebral Palsy in Children

This study is looking at how intrathecal baclofen (ITB) affects children with dystonic cerebral palsy (CP). ITB is a medication delivered directly into the fluid around the spinal cord to help manage muscle stiffness and spasms. The main goals are to see if ITB reduces dystonia (involuntary muscle contractions), identify which children respond best to ITB, and create a better way to measure improvement. Researchers will gradually increase the ITB dose over 12 months using a careful plan to find the best balance of benefits and side effects. To join, children must be under 18, weigh at least 18 kg (about 40 lbs), have a CP diagnosis with significant dystonia, and be considered for ITB treatment by their doctor. The study aims to understand the effects of ITB on this group of children.

Study design
This is an interventional study planning to enroll 65 participants. It will follow participants over time to see the effects of intrathecal baclofen.
What's involved
Participants will have their ITB dosage gradually increased over a 12-month period. Assessments will be done at the start, 3 months, 6 months, and 12 months after ITB begins.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting ITB treatment.

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NCT06606574

Intrathecal Baclofen and Pediatric Dystonia

Recruiting
NAUp to 17InterventionalTreatment
Baylor College of Medicine
~65 participants
Updated 2025-07-30 on ClinicalTrials.gov
What's tested:Titration protocol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Barry-Albright Dystonia Scale (BADS)
Measured over Baseline (pre-ITB initiation) , 3 months, 6 months, 12 months post ITB initiation

Conditions

Dystonic Cerebral Palsy

Explore related trials

Cerebral PalsyDystonia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Sruthi P Thomas, MD, PhD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Sruthi Thomas, MD, PhD
[email protected]
832-824-4945
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Barry-Albright Dystonia Scale (BADS)Baseline (pre-ITB initiation) , 3 months, 6 months, 12 months post ITB initiation

    The BADS was created based on the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS), a tool originally designed to detect cervical dystonia in adults.The BADS tailors this scale for detecting dystonia in CP and acquired brain injury in individuals with limitations in cognition and physical ability. Scoring focuses on posturing and involuntary dystonic movements to detect potential changes in dystonia that affect ease of care and comfort. It does not assess functional tasks. It has moderate internal consistency and inter-rater reliability. It has effectively detected change with ITB. The BADS was also found to have the greatest clinical utility for children with dystonic CP