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New treatment option for Dystonic Cerebral Palsy
Official title Intrathecal Baclofen and Pediatric Dystonia
ClinicalTrials.gov ID: NCT06606574
What this study is testing
- What it's testing
- 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 composite outcome measure for dystonic CP.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join if
- 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...
- Child and family are willing to participate in full schedule of formal assessments, spanning pre-implantation, every 2 weeks until ideal intrathecal...
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.