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

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ClinicalTrials.gov Identifier: NCT00572845
Recruitment Status : Terminated (Unable to recruit enough participants.)
First Posted : December 13, 2007
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Basal Energy Expenditure Spasticity Other: Weaning of Antispasticity Medication Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation
Study Start Date : January 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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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
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Publications:
Clasey JL, Gater DR. Body Composition Assessment in Adults with Spinal Cord Injury. Topics in Spinal Cord Injury Rehabilitation. 2007;12(4):8-19.

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00572845    
Other Study ID Numbers: HM11352
First Posted: December 13, 2007    Key Record Dates
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:
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Muscle Spasticity
Spinal Cord Injuries
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