Intrathecal Baclofen and Pediatric Dystonia

Launched by BAYLOR COLLEGE OF MEDICINE · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called intrathecal baclofen (ITB) on children with dystonic cerebral palsy (CP), a condition that causes muscle stiffness and uncontrolled movements. The researchers want to find out if ITB can help reduce these symptoms and improve overall function in these children. They will also look at which children respond best to the treatment and develop a way to measure improvements in their condition more accurately.

To participate, children need to be at least 4 years old and weigh enough for an ITB pump to be safely implanted. They must have a confirmed diagnosis of CP with specific assessments showing they have dystonia, and their family must be committed to attending several additional clinic visits over the next year for evaluations and questionnaires. Throughout the trial, doctors will carefully manage the medication dosage to ensure the best possible results while minimizing side effects. This study aims to provide valuable insights into how ITB can help improve the lives of children with dystonic CP.

Gender

ALL

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