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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Terminated
CT.gov ID
NCT00572845
Collaborator
(none)
20
1
1
30
0.7

Study Details

Study Description

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
  • Other: Weaning of Antispasticity Medication
N/A

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

Study Type:
Interventional
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 :
Jan 1, 2008
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

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

Primary Outcome Measures

  1. Increase in Basal Energy Expenditure [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00572845
Other Study ID Numbers:
  • HM11352
First Posted:
Dec 13, 2007
Last Update Posted:
Feb 23, 2016
Last Verified:
Feb 1, 2016
Keywords provided by Virginia Commonwealth University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2016