Effects of intrathecal baclofen on children with dystonic cerebral palsy
PREDICT-ITB: Predicting Response in Children With Dystonic Cerebral Palsy to Intrathecal Baclofen
This study is testing if a medication called intrathecal baclofen can help reduce muscle stiffness and improve movement in children with dystonic cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06606574 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with dystonic cerebral palsy who are eligible for intrathecal baclofen treatment and meet specific inclusion criteria.
Not a fit: Patients who have an emergent need for ITB or have received certain injections within the specified time frame may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for children with dystonic cerebral palsy by reducing abnormal muscle tone and associated complications.
How similar studies have performed: While the use of intrathecal baclofen is common in managing dystonia, this study aims to provide more precise data on its efficacy, making it a novel approach in this specific population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.