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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803464
• Other study ID #: 1R15HD071397-01
• Secondary ID: IRB # 115648-111
• Status: Completed
• Phase: N/A
• First received: February 27, 2013
• Last updated: February 20, 2018
• Start date: March 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2018
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware
United States	Alfred I. duPont Hospital for Children, Nemours	Wilmington	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
University of Delaware	Alfred I. duPont Hospital for Children, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Johnson DL, Miller F, Subramanian P, Modlesky CM. Adipose tissue infiltration of skeletal muscle in children with cerebral palsy. J Pediatr. 2009 May;154(5):715-20. doi: 10.1016/j.jpeds.2008.10.046. Epub 2008 Dec 25. — View Citation

Judex S, Boyd S, Qin YX, Turner S, Ye K, Müller R, Rubin C. Adaptations of trabecular bone to low magnitude vibrations result in more uniform stress and strain under load. Ann Biomed Eng. 2003 Jan;31(1):12-20. — View Citation

Modlesky CM, Subramanian P, Miller F. Underdeveloped trabecular bone microarchitecture is detected in children with cerebral palsy using high-resolution magnetic resonance imaging. Osteoporos Int. 2008 Feb;19(2):169-76. Epub 2007 Oct 26. — View Citation

Modlesky CM, Whitney DG, Carter PT, Allerton BM, Kirby JT, Miller F. The pattern of trabecular bone microarchitecture in the distal femur of typically developing children and its effect on processing of magnetic resonance images. Bone. 2014 Mar;60:1-7. do — View Citation

Modlesky CM, Whitney DG, Singh H, Barbe MF, Kirby JT, Miller F. Underdevelopment of trabecular bone microarchitecture in the distal femur of nonambulatory children with cerebral palsy becomes more pronounced with distance from the growth plate. Osteoporos — View Citation

Rubin C, Turner AS, Müller R, Mittra E, McLeod K, Lin W, Qin YX. Quantity and quality of trabecular bone in the femur are enhanced by a strongly anabolic, noninvasive mechanical intervention. J Bone Miner Res. 2002 Feb;17(2):349-57. — View Citation

Ward K, Alsop C, Caulton J, Rubin C, Adams J, Mughal Z. Low magnitude mechanical loading is osteogenic in children with disabling conditions. J Bone Miner Res. 2004 Mar;19(3):360-9. Epub 2004 Jan 27. — View Citation

Wren TA, Lee DC, Hara R, Rethlefsen SA, Kay RM, Dorey FJ, Gilsanz V. Effect of high-frequency, low-magnitude vibration on bone and muscle in children with cerebral palsy. J Pediatr Orthop. 2010 Oct-Nov;30(7):732-8. doi: 10.1097/BPO.0b013e3181efbabc. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Structure	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	Muscle Volume	Change in muscle volume of the midleg from baseline to 6 months, as measured by MRI	baseline to 6 months
Secondary	Bone Mass	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