Intrathecal Baclofen and Pediatric Dystonia
Recruiting
N/A
Interventional Study
Dystonic Cerebral Palsy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 17
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 65 (estimated)
- Sponsor
- Baylor College of Medicine · Other
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About This Trial
The goal of this clinical trial is to better understand the effects of intrathecal baclofen (ITB) on children with dystonic cerebral palsy (CP).
The main questions this study aims to answer are:
(1) Determine if ITB reduces dystonia while identifying other potential benefits, (2) Identify the characteristics of children with the best response to ITB (3) Develop a holistically representative comp…
Trial Locations
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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
* T…
Contacts