Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation

Spasticity Clinical Trial

Official title:

Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00572845
• Other study ID #: HM11352
• Status: Terminated
• Phase: N/A
• First received: December 11, 2007
• Last updated: February 19, 2016
• Start date: January 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if there is a relationship between spasticity and relative changes in Basal Energy Expenditure in persons with spinal cord injury.

Description:

Obesity is at epidemic proportions in the population with spinal cord injury (SCI), and is likely the mediator of the metabolic syndrome in this special population. Recent literature reviews have suggested that obesity is present in > 67% of persons with SCI. Additionally, recent studies have demonstrated the causal relationship between adipose tissue accumulation and vascular inflammation, dyslipidemia, insulin resistance / glucose intolerance, hypertension and thromboemboli.

Obesity in SCI occurs because of acute and ongoing positive energy balance, i.e., greater caloric intake than energy expenditure. Total Daily Energy Expenditure (TDEE) in SCI is reduced primarily because of muscular atrophy and diminished muscular contraction; pharmacological treatment of spasticity possibly reduces energy expenditure (EE) even further, but has not been evaluated to date. TDEE is comprised of three components: Basal Energy Expenditure (BEE), Thermic Effect of Activity (TEA) and Thermic Effect of Food (TEF). Of the three, BEE contributes the greatest amount (65-75% TDEE) and is the most sensitive to changes in spasticity.

Dampening spasticity has been reported to increase weight gain and necessitate reduced caloric intake in a child with spastic quadriplegia. Similarly, athetosis in patients with cerebral palsy increased resting metabolic rate (RMR) as compared to control subjects with no athetotic movements. Although several studies have reported energy requirements for persons with neurodevelopmental disabilities, and even SCI, however, none have attempted to measure the metabolic effect of spasticity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• C1-T10 SCI at least 1 year post injury

• Spasticity in the legs

• Veteran

Exclusion Criteria:

• Recent increase in spasticity

• Botox within 6 months

• Phenol within 2 years

• Prior surgery for spasticity

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Basal Energy Expenditure
• Muscle Spasticity
• Spasticity
• Spinal Cord Injuries

Intervention

Other:
• Weaning of Antispasticity Medication
Weaning of antispasticity medication over a three day period and then titration back to previous dose over a three day period.

Locations

Country	Name	City	State
United States	McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (13)

Bauman WA, Spungen AM, Wang J, Pierson RN Jr. The relationship between energy expenditure and lean tissue in monozygotic twins discordant for spinal cord injury. J Rehabil Res Dev. 2004 Jan-Feb;41(1):1-8. — View Citation

Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. — View Citation

Buchholz AC, McGillivray CF, Pencharz PB. Differences in resting metabolic rate between paraplegic and able-bodied subjects are explained by differences in body composition. Am J Clin Nutr. 2003 Feb;77(2):371-8. — View Citation

Clasey JL, Gater DR. Body Composition Assessment in Adults with Spinal Cord Injury. Topics in Spinal Cord Injury Rehabilitation. 2007;12(4):8-19.

Cox SA, Weiss SM, Posuniak EA, Worthington P, Prioleau M, Heffley G. Energy expenditure after spinal cord injury: an evaluation of stable rehabilitating patients. J Trauma. 1985 May;25(5):419-23. — View Citation

Dickerson RN, Brown RO, Gervasio JG, Hak EB, Hak LJ, Williams JE. Measured energy expenditure of tube-fed patients with severe neurodevelopmental disabilities. J Am Coll Nutr. 1999 Feb;18(1):61-8. — View Citation

Gater DR Jr. Obesity after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):333-51, vii. Review. — View Citation

Gater DR. Pathophysiology of obesity after spinal cord injury. Topics in Spinal Cord Injury Rehabilitation. 2007;12(4):20-34.

Gorgey AS, Gater DR. Prevalence of Obesity after Spinal Cord Injury. Topics in Spinal Cord Injury Rehabilitation. 2007;12(4):1-7.

Hemingway C, McGrogan J, Freeman JM. Energy requirements of spasticity. Dev Med Child Neurol. 2001 Apr;43(4):277-8. — View Citation

Penn RD. Intrathecal baclofen for severe spasticity. Ann N Y Acad Sci. 1988;531:157-66. — View Citation

Rodriguez DJ, Benzel EC, Clevenger FW. The metabolic response to spinal cord injury. Spinal Cord. 1997 Sep;35(9):599-604. — View Citation

Rodriguez DJ, Clevenger FW, Osler TM, Demarest GB, Fry DE. Obligatory negative nitrogen balance following spinal cord injury. JPEN J Parenter Enteral Nutr. 1991 May-Jun;15(3):319-22. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in Basal Energy Expenditure		7 days	No