Cerebral PalsyNCT00503620
The Effect of Botox on Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Shriners Hospitals for Children at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Botulinum Toxin A
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with spastic hemiplegic or diplegic CP, GMFCS Level I or II
Who may be able to join
- A diagnosis of spastic hemiplegic or diplegic CP
- Children must be ambulatory without the use of assistive devices
- Children must be between the ages of 4 and 12 years
- Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees)
- Children must be seizure-free or seizure controlled
- Children must have visuoperceptual skills and cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection
- Children's passive range of motion in lower extremity joints must be less than 20 degrees of flexion contracture at the hips as measured by the Thomas Test, at least 20 degrees of hip abduction bilaterally, les than 0 degrees of knee flexion contracture, popliteal angle less than 55 degrees, and at least 0 degrees of ankle dorsiflexion with the knee extended while the foot is in varus
- Children who are planning to undergo botulinum toxin injections of the gastrocnemius and/or soleus muscles without serial casting as clinically dictated for the treatment of muscle spasticity
Who cannot join
- Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia)
- Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.
- Children who have a metallic or electrical implants
- Children who are unable to stay in the MRI machine for the 8 to 10 minute duration of the exam.
- Children who have a history of claustrophobia.
- Female children cannot be pregnant. A pregnancy test will be given if it is possible that the child can become pregnant, to ascertain whether or not the child is pregnant.
- Children who are planning to receive serial casting post botox injection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Philadelphia, Pennsylvania, 19140
About this study
Official title: The Effect of Botulinum Toxin on Neuromuscular Function in the Child 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 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.
- Conditions
- Cerebral Palsy
- Being tested
- Botulinum Toxin A
- Keywords
- Cerebral Palsy, Botulinum Toxin, Neuromuscular Function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin ADrug
Injection into the gastrocnemius/soleus muscles for spasticity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startJan 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- United Cerebral Palsy Foundation
- Investigators
- Richard T Lauer, PhD, Principal investigator, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503620
- Sponsor's protocol ID
- R-784-06
- Status last verified
- Jan 2009
- First submitted
- 18 Jul 2007
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Botulinum Toxin on Neuromuscular Function in the Child With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00503620
- Acronym / sponsor ID
- R-784-06
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Botulinum Toxin, Neuromuscular Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- United Cerebral Palsy Foundation
- Study start
- Jan 2007
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with spastic hemiplegic or diplegic CP, GMFCS Level I or II
Key inclusion criteria (8 listed)
- A diagnosis of spastic hemiplegic or diplegic CP
- Children must be ambulatory without the use of assistive devices
- Children must be between the ages of 4 and 12 years
- Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees)
- Children must be seizure-free or seizure controlled
Key exclusion criteria (7 listed)
- Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia)
- Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.
- Children who have a metallic or electrical implants
- Children who are unable to stay in the MRI machine for the 8 to 10 minute duration of the exam.
- Children who have a history of claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin AInjection into the gastrocnemius/soleus muscles for spasticity | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Lauer, PhD principal investigator
Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Shriners Hospitals for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2010.