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| Sponsored by: |
Virginia Commonwealth University |
|---|---|
| Information provided by: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00572845 |
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: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation |
| Estimated Enrollment: | 36 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ajit B Pai, MD | 804-675-6741 | apai@vcu.edu |
| 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 | |
| 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
| Responsible Party: | McGuire VA Medical Center ( David Gater, MD, PhD ) |
| Study ID Numbers: | HM11352 |
| Study First Received: | December 11, 2007 |
| Last Updated: | June 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00572845 |
| Health Authority: | United States: Institutional Review Board |
|
Basal Energy Expenditure Spasticity Modified Ashworth Scale Penn Spasm Frequency Score |
|
Spasm Spinal Cord Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Spinal Cord Injuries |
Signs and Symptoms Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neurologic Manifestations |
|
Neuromuscular Manifestations Nervous System Diseases |
