Clinical trial NCT00572845: Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation
Official title: Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Basal Energy Expenditure
Spasticity
Keywords: Basal Energy Expenditure
Spasticity
Modified Ashworth Scale
Penn Spasm Frequency Score
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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 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

Primary outcomes:
measure: Increase in Basal Energy Expenditure
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: McGuire VA Medical Center
name: David R Gater, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VCU Department of Physical Medicine and Rehabilitation
name: David X Cifu, MD
role: STUDY_CHAIR
References:
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