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NCT00503620 · ClinicalTrials.gov registry record
The Effect of Botox on Children With Cerebral Palsy
A clinical trial, sponsored by Shriners Hospitals for Children.
- Completed
- Registry status
- 11
- Enrollment target
NCT00503620 is a clinical trial that has completed, run by Shriners Hospitals for Children. The registered enrollment target is 11 participants.
The verdict
NCT00503620 has completed, sponsored by Shriners Hospitals for Children.
- COMPLETED
- Registry status
- 11 participants
- Enrollment target
Study Summary
Botulinum toxin injections are a common form of treatment for children with cerebral palsy to help reduce muscle tightness and help them walk without resorting to surgery. While the treatment is beneficial, it requires that the therapy be repeated every six months, which can be costly and may eventually result in the therapy not being effective over time. The study being conducted at Shriners Hospitals for Children, Philadelphia, will examine the effects of botulinum toxin injections, not only on walking, but on the changes it causes in the muscle, brain and spinal cord. The changes in the muscle, brain and spinal cord, called neuromuscular plasticity, have not been extensively examined in response to botulinum toxin, and could provide insight into how botulinum toxin works and how to make it more effective. This study will focus on children with cerebral palsy between the ages of 4 and 12 years, with only one leg involved and who would normally be receiving botulinum toxin injections of the lower leg to help improve walking. The children will be asked to come into the hospital for a full day before they receive the injection, and then again after four and twelve weeks to look at the changes in the muscle, brain and spinal cord. This will involve recording them while they walk, measurements of the muscle reflexes, and recording their brain activity while the move their ankle (also known as functional magnetic resonance imaging or fMRI). A group of children with typical development will also be asked to participate in the study to act as a comparison group. The researchers believe that examining the changes in the muscles, brain and spinal cord in response to the injection will aid in the understanding how better to use botulinum toxin to achieve better or longer lasting changes.
Interventions
- DRUG Botulinum Toxin A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2007-01 |
| Est. Completion | 2009-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00503620
The ClinicalTrials.gov registry entry for NCT00503620 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shriners Hospitals for Children, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Botulinum Toxin A is the first listed.
NCT00503620 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00503620 about?
NCT00503620 is a clinical study titled "The Effect of Botox on Children With Cerebral Palsy". Botulinum toxin injections are a common form of treatment for children with cerebral palsy to help reduce muscle tightness and help them walk without resorting to surgery. While the treatment is beneficial, it requires that the therapy be repeated every six months, which can be costly and may eventu...
What is the current status of trial NCT00503620?
This trial is currently completed. The enrollment target is 11 participants. The study started on 2007-01. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00503620?
The interventions under investigation include: Botulinum Toxin A (DRUG).
Who is sponsoring clinical trial NCT00503620?
This trial is sponsored by Shriners Hospitals for Children, which has 40 total clinical trials registered on ClinicalTrials.gov.
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