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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01803464
First received: February 27, 2013
Last updated: September 9, 2015
Last verified: September 2015
  Purpose
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 intensity 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 Intervention
Cerebral Palsy
Muscle Spasticity
Other: Botox plus low-magnitude vibration
Drug: Botox

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Botox and Vibration on Bone in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by University of Delaware:

Primary Outcome Measures:
  • Bone structure [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    MRI will be used to assess bone structure at baseline and 6 months post baseline.


Secondary Outcome Measures:
  • Bone mass [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Dual-energy X-ray absorptiometry will be used to assess bone mass at baseline and 6 months post baseline.

  • Serum [ Time Frame: Baseline, 1 month, and 6 months ] [ Designated as safety issue: No ]
    Serum will be used to assess bone turnover at baseline and 1 month and 6 months post baseline.

  • Muscle volume [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    MRI will be used to assess muscle volume at baseline and 6 months post baseline.


Enrollment: 29
Study Start Date: March 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botox plus low-magnitude vibration
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.
Other: Botox plus low-magnitude vibration
Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study.
Other Name: Drug plus device
Experimental: Botox
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.
Drug: Botox
Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study.
No Intervention: Cerebral palsy control
Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
No Intervention: Typically developing control
Typically developing children without cerebral palsy will serve as controls.

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 intensity 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 DXA.

  Eligibility

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

Inclusion Criteria:

  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. Have not had Botox treatment in the lower extremities within the last 1 year.
  5. A score of 1-4 on the gross motor function scale (GMFCS).
  6. Do not have metal rods in both legs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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  IRB # 115648-11 
Study First Received: February 27, 2013
Last Updated: September 9, 2015
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Delaware:
Botox
Muscle strength

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Muscle Spasticity
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
OnabotulinumtoxinA
Botulinum Toxins, Type A
AbobotulinumtoxinA
IncobotulinumtoxinA
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

ClinicalTrials.gov processed this record on July 28, 2016