Effects of intrathecal baclofen on children with dystonic cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of intrathecal baclofen (ITB) on children diagnosed with dystonic cerebral palsy (CP). The study aims to determine if ITB can effectively reduce dystonia and identify characteristics of children who respond best to this treatment. Over a 12-month period, participants will undergo a standardized titration protocol to gradually adjust their ITB dosages, allowing for precise medication management. The study will also evaluate the overall effects of ITB on spasticity and other factors influencing dystonia.

Why it matters

Who can join: the full rules

Inclusion Criteria for pre-implant ITB subjects:

* 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

Inclusion Criteria for post-implant ITB subjects:

* 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.

Inclusion criteria for VDR subjects:

* 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.

Inclusion criteria for DBS subjects:

* 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

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
* Foster care placement or incarceration
* Family not willing to participate in schedule of assessments

Where it's running

• Texas Childrens Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Sruthi P Thomas, MD, PhD — Baylor College of Medicine
• Study coordinator: Sruthi Thomas, MD, PhD
• Email: spthomas@texaschildrens.org
• Phone: 832-824-4945

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep brain stimulation for movement disorders in children with cerebral palsy

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• Understanding how trihexyphenidyl works in children with dystonic cerebral palsy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.