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

February 20, 2018 updated by: Christopher Modlesky, University of Delaware
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19716
        • University of Delaware
      • Wilmington, Delaware, United States, 19899
        • Alfred I. duPont Hospital for Children, Nemours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Volume
Time Frame: baseline to 6 months
Change in muscle volume of the midleg from baseline to 6 months, as measured by MRI
baseline to 6 months
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)
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Alfred I. duPont Hospital for Children

Investigators

  • Principal Investigator: Christopher Modlesky, PhD, University of Delaware
  • Principal Investigator: Freeman Miller, MD, Nemours/Alfred I DuPont Hospital for Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R15HD071397-01 (U.S. NIH Grant/Contract)
  • IRB # 115648-11 (Other Identifier: Alfred I. duPont Hospital for the Children)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Within 30 days of the request.

IPD Sharing Access Criteria

Data access requests will be reviewed by the PIs. Requestors will be required to sign a Data Access Agreement.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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