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

This study has been terminated.
(Unable to recruit enough participants.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572845
First Posted: December 13, 2007
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
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.

Condition Intervention
Basal Energy Expenditure Spasticity Other: Weaning of Antispasticity Medication

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Increase in Basal Energy Expenditure [ Time Frame: 7 days ]

Enrollment: 20
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572845


Locations
United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: David R Gater, MD, PhD McGuire VA Medical Center
Study Chair: David X Cifu, MD VCU Department of Physical Medicine and Rehabilitation
  More Information

Publications:
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.
Gater DR Jr. Obesity after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):333-51, vii. Review.
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.
Hemingway C, McGrogan J, Freeman JM. Energy requirements of spasticity. Dev Med Child Neurol. 2001 Apr;43(4):277-8.
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.
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.
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.
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7.
Penn RD. Intrathecal baclofen for severe spasticity. Ann N Y Acad Sci. 1988;531:157-66.
Gater DR. Pathophysiology of obesity after spinal cord injury. Topics in Spinal Cord Injury Rehabilitation. 2007;12(4):20-34.
Clasey JL, Gater DR. Body Composition Assessment in Adults with Spinal Cord Injury. Topics in Spinal Cord Injury Rehabilitation. 2007;12(4):8-19.
Gorgey AS, Gater DR. Prevalence of Obesity after Spinal Cord Injury. Topics in Spinal Cord Injury Rehabilitation. 2007;12(4):1-7.

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00572845     History of Changes
Other Study ID Numbers: HM11352
First Submitted: December 11, 2007
First Posted: December 13, 2007
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Virginia Commonwealth University:
Basal Energy Expenditure
Spasticity
Modified Ashworth Scale
Penn Spasm Frequency Score

Additional relevant MeSH terms:
Spinal Cord Injuries
Muscle Spasticity
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms


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