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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Basal Energy Expenditure, Spasticity

Intervention / Treatment
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* Other: Weaning of Antispasticity Medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Weaning of antispasticity medication over a three day period and then titration back to previous dose over a three day period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Basal Energy Expenditure |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Basal Energy Expenditure, Spasticity, Modified Ashworth Scale, Penn Spasm Frequency Score