Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation
NCT ID: NCT00572845
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
20 participants
INTERVENTIONAL
2008-01-31
2010-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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1
Weaning of Spasticity Medication over a three day period while measuring Modified Ashworth Scale and Penn Spasm Frequency Score. Then titration of medication back to previous dose over a three day period.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Spasticity in the legs
* Veteran
Exclusion Criteria
* Botox within 6 months
* Phenol within 2 years
* Prior surgery for spasticity
18 Years
ALL
Yes
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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David R Gater, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
McGuire VA Medical Center
David X Cifu, MD
Role: STUDY_CHAIR
VCU Department of Physical Medicine and Rehabilitation
Locations
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McGuire VA Medical Center
Richmond, Virginia, United States
Countries
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References
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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. doi: 10.1093/ajcn/77.2.371.
Gater DR Jr. Obesity after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):333-51, vii. doi: 10.1016/j.pmr.2007.03.004.
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. doi: 10.1682/jrrd.2004.01.0001.
Hemingway C, McGrogan J, Freeman JM. Energy requirements of spasticity. Dev Med Child Neurol. 2001 Apr;43(4):277-8. doi: 10.1017/s0012162201000524.
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. doi: 10.1080/07315724.1999.10718828.
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.
Rodriguez DJ, Benzel EC, Clevenger FW. The metabolic response to spinal cord injury. Spinal Cord. 1997 Sep;35(9):599-604. doi: 10.1038/sj.sc.3100439.
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. doi: 10.1177/0148607191015003319.
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
Penn RD. Intrathecal baclofen for severe spasticity. Ann N Y Acad Sci. 1988;531:157-66. doi: 10.1111/j.1749-6632.1988.tb31822.x. No abstract available.
Gorgey AS, Gater DR Jr. Prevalence of Obesity After Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2007 Spring;12(4):1-7. doi: 10.1310/sci1204-1.
Other Identifiers
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HM11352
Identifier Type: -
Identifier Source: org_study_id
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