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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Virginia Commonwealth University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00572845
First received: December 11, 2007
Last updated: July 1, 2010
Last verified: July 2010
History of Changes
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Increase in Basal Energy Expenditure [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2008
Estimated Study Completion Date: July 2010
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572845

Contacts
Contact: Ajit B Pai, MD 804-675-6741 apai@vcu.edu

Locations
United States, Virginia
McGuire VA Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: Ajit B Pai, MD     804-675-6741     apai@vcu.edu    
Principal Investigator: David R Gater, MD, PhD            
Sub-Investigator: Ajit B Pai, MD            
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:
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: David Gater, MD, PhD, McGuire VA Medical Center
ClinicalTrials.gov Identifier: NCT00572845     History of Changes
Other Study ID Numbers: HM11352
Study First Received: December 11, 2007
Last Updated: July 1, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013