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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:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00572845
First received: December 11, 2007
Last updated: February 19, 2016
Last verified: February 2016
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 
Study First Received: December 11, 2007
Last Updated: February 19, 2016
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:
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

ClinicalTrials.gov processed this record on December 06, 2016