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NCT06606574 · ClinicalTrials.gov registry record · NA
Intrathecal Baclofen and Pediatric Dystonia
A NA study of Dystonic Cerebral Palsy, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT06606574: Recruiting NA study of Dystonic Cerebral Palsy, sponsored by Baylor College of Medicine.
NCT06606574 is a NA study of Dystonic Cerebral Palsy that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06606574, a NA study of Dystonic Cerebral Palsy, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
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. This study will evaluate patient improvement by using a standardized titration, or medication management, protocol to gradually increase the childs ITB dosages over a 12-month period until they achieve maximum benefit with minimal to no side effects. This titration protocol mimics what is currently done through routine care but with more precision. This study will also directly measure the global effects of ITB, taking into account spasticity, known dystonia triggers (e.g. pain), and patterns of CNS injury that cause dystonia. Participants will: 1. Complete a total of 4 additional clinic visits outside usual care. These appointments will be with physical and occupational therapists as well as the study PI to complete evaluations for dystonia, spasticity, and function. 2. Complete several questionnaires at these visits. The total duration of the study for an individual child will be 12 months.
Primary Outcome
The BADS was created based on the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS), a tool originally designed to detect cervical dystonia in adults.The BADS tailors this scale for detecting dystonia in CP and acquired brain injury in individuals with limitations in cognition and physical ability. Scoring focuses on posturing and involuntary dystonic movements to detect potential changes in dystonia that affect ease of care and comfort. It does not assess functional tasks. It has moderate inter
Conditions Studied
Interventions
- OTHER Titration protocol
Study Locations (1)
Texas
- Texas Childrens Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2029-08-31 |
| Phase | NA |
What NCT06606574 shows while recruiting
NCT06606574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Dystonic Cerebral Palsy appearing as the primary indexed condition, and to 1 intervention - of which Titration protocol is the first listed.
NCT06606574 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06606574 about?
NCT06606574 is a clinical study titled "Intrathecal Baclofen and Pediatric Dystonia". 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 char...
What is the current status of trial NCT06606574?
This trial is currently recruiting. It is a NA study. The enrollment target is 65 participants. The study started on 2024-11-01. Estimated completion is 2029-08-31.
What conditions does trial NCT06606574 study?
This clinical trial studies the following conditions: Dystonic Cerebral Palsy.
What interventions are being tested in trial NCT06606574?
The interventions under investigation include: Titration protocol (OTHER).
Who is sponsoring clinical trial NCT06606574?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06606574 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06606574's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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