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Effect of Botox and Vibration on Bone in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT01803464
Recruitment Status : Completed
First Posted : March 4, 2013
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
Alfred I. duPont Hospital for Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Christopher Modlesky, University of Delaware

Brief Summary:
Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000 individuals in the U.S. An estimated 70-80% of these individuals have spasticity which affects ambulation and requires management. Therefore, the treatment of spasticity is a primary goal of interventions for children with CP. One treatment widely used to reduce spasticity is Botox because of its ability to temporarily paralyze a muscle. However, no studies have determined the effect of Botox treatment on bone in humans. Also, a low magnitude vibration treatment has been shown to improve bone structure in the lower extremity bones of children with CP. The aims of this study are: 1) to determine the effect of Botox treatment in conjunction with a daily vibration treatment on bone mass and bone structure in children with spastic CP, and 2) to identify the mechanism that underlies the effect of Botox and vibration on bone.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Muscle Spasticity Device: Low-magnitude vibration Drug: Botox Not Applicable

Detailed Description:

The investigators have been working with children diagnosed with cerebral palsy (CP) for the past 10 years. The investigators have found that bone structure is markedly underdeveloped and bone strength is severely compromised in children with CP. Also, an increased fracture rate has been observed in the lower extremity bones of children with CP. There is evidence that Botox, which is used to treat spasticity in CP, can improve motor function; however the effect of Botox on human bone is unknown. There is also evidence that low magnitude vibration treatment can improve bone mass and bone structure. The overall goal of this current research study is to investigate the effect and mechanism of action of Botox and vibration on bone in children with CP. The investigators will also examine the effect of Botox on muscle volume.

A total of 36 participants will participate in this study. The investigators will assess bone structure and muscle volume using MRI. The investigators will assess bone mass using dual-energy X-ray absorptiometry (DXA).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
Study Start Date : March 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botox plus low-magnitude vibration
Cerebral palsy and Botox + vibration
Device: Low-magnitude vibration
Children will receive a daily low-magnitude vibration treatment.

Drug: Botox
Children who are candidates to receive Botox as part of their standard of care.

Experimental: Botox
Cerebral palsy and Botox
Drug: Botox
Children who are candidates to receive Botox as part of their standard of care.

No Intervention: Cerebral palsy control
Cerebral palsy without treatment
No Intervention: Typically developing control
Typically developing



Primary Outcome Measures :
  1. Bone Structure [ Time Frame: baseline to 6 months ]
    Change in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI.


Secondary Outcome Measures :
  1. Muscle Volume [ Time Frame: baseline to 6 months ]
    Change in muscle volume of the midleg from baseline to 6 months, as measured by MRI

  2. Bone Mass [ Time Frame: baseline to 6 months ]
    Change in bone mineral content in the distal femur from baseline to 6 months, as measured by dual-energy X-ray absorptiometry (DXA)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion (Children with CP):

  1. Have spastic CP
  2. Between 2-12 years of age
  3. Recommended for Botox treatment by their physician as part of their clinical care. Those who accept Botox treatment and those who do not accept Botox treatment are both eligible for the study.
  4. A score of 1-4 on the gross motor function classification scale (GMFCS)

Exclusion (Children with CP):

  1. Botox treatment in the lower extremities within the last year
  2. Metal rods in both legs

Inclusion (Typically developing children):

  1. Between 2 and 12 years of age.
  2. Match a child with CP for sex, age and race.

Exclusion(Typically developing children):

  1. Neurological disorder
  2. Surgery in the lower extremities within the last year.
  3. Chronic medication use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803464


Locations
United States, Delaware
University of Delaware
Newark, Delaware, United States, 19716
Alfred I. duPont Hospital for Children, Nemours
Wilmington, Delaware, United States, 19899
Sponsors and Collaborators
University of Delaware
Alfred I. duPont Hospital for Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Christopher Modlesky, PhD University of Delaware
Principal Investigator: Freeman Miller, MD Nemours/Alfred I duPont Hospital for Children

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Modlesky, Associate Professor, University of Delaware
ClinicalTrials.gov Identifier: NCT01803464     History of Changes
Other Study ID Numbers: 1R15HD071397-01 ( U.S. NIH Grant/Contract )
IRB # 115648-11 ( Other Identifier: Alfred I. duPont Hospital for the Children )
1R15HD071397-01 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2013    Key Record Dates
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Time Frame: Within 30 days of the request.
Access Criteria: Data access requests will be reviewed by the PIs. Requestors will be required to sign a Data Access Agreement.

Keywords provided by Christopher Modlesky, University of Delaware:
Botox
Muscle strength

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents