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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by Virginia Commonwealth University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT00572845

First received: December 11, 2007

Last updated: July 1, 2010

Last verified: July 2010

History of Changes

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:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

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 ]


Estimated Enrollment:	36
Study Start Date:	January 2008
Estimated Study Completion Date:	July 2010
Estimated 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
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

Contacts


Contact: Ajit B Pai, MD	804-675-6741	apai@vcu.edu

Locations


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

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:

Buchholz AC, McGillivray CF, Pencharz PB. Differences in resting metabolic rate between paraplegic and able-bodied subjects are explained by differences in body composition. Am J Clin Nutr. 2003 Feb;77(2):371-8.

Gater DR Jr. Obesity after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):333-51, vii. Review.

Bauman WA, Spungen AM, Wang J, Pierson RN Jr. The relationship between energy expenditure and lean tissue in monozygotic twins discordant for spinal cord injury. J Rehabil Res Dev. 2004 Jan-Feb;41(1):1-8.

Hemingway C, McGrogan J, Freeman JM. Energy requirements of spasticity. Dev Med Child Neurol. 2001 Apr;43(4):277-8.

Dickerson RN, Brown RO, Gervasio JG, Hak EB, Hak LJ, Williams JE. Measured energy expenditure of tube-fed patients with severe neurodevelopmental disabilities. J Am Coll Nutr. 1999 Feb;18(1):61-8.

Cox SA, Weiss SM, Posuniak EA, Worthington P, Prioleau M, Heffley G. Energy expenditure after spinal cord injury: an evaluation of stable rehabilitating patients. J Trauma. 1985 May;25(5):419-23.

Rodriguez DJ, Benzel EC, Clevenger FW. The metabolic response to spinal cord injury. Spinal Cord. 1997 Sep;35(9):599-604.

Rodriguez DJ, Clevenger FW, Osler TM, Demarest GB, Fry DE. Obligatory negative nitrogen balance following spinal cord injury. JPEN J Parenter Enteral Nutr. 1991 May-Jun;15(3):319-22.

Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7.

Penn RD. Intrathecal baclofen for severe spasticity. Ann N Y Acad Sci. 1988;531:157-66.

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:	David Gater, MD, PhD, McGuire VA Medical Center
ClinicalTrials.gov Identifier:	NCT00572845 History of Changes
Other Study ID Numbers:	HM11352
Study First Received:	December 11, 2007
Last Updated:	July 1, 2010
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:


Muscle Spasticity Spinal Cord Injuries Central Nervous System Diseases Muscle Hypertonia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases	Neurologic Manifestations Neuromuscular Manifestations Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

ClinicalTrials.gov processed this record on March 03, 2015

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