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

Status Terminated

Clinical Trial 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.

Clinical Trial 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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00572845
Study type	Interventional
Source	Virginia Commonwealth University
Contact
Status	Terminated
Phase	N/A
Start date	January 2008
Completion date	July 2010

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06150729` - Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy
Completed	`NCT02400619` - Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT	Phase 1
Completed	`NCT01945684` - A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity	Phase 3
Completed	`NCT02261142` - Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS	N/A
Completed	`NCT01444794` - Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
Terminated	`NCT02877836` - Functional MRI and DTI in the Preoperative Assessment of Dystonia	N/A
Completed	`NCT02334683` - Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia	N/A
Completed	`NCT02170779` - Developing and Testing a Comprehensive MS Spasticity Management Program	Phase 2
Recruiting	`NCT05674604` - Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting
Not yet recruiting	`NCT05926596` - Leg Stretching Using an Exoskeleton on Demand for People With Spasticity	N/A
Terminated	`NCT01712087` - Long-term Surveillance of the MedStream Programmable Infusion System
Completed	`NCT03906305` - Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients	N/A
Completed	`NCT03302741` - Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings	Phase 4
Completed	`NCT02291159` - Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke	N/A
Completed	`NCT01743651` - Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis	Phase 3
Completed	`NCT01523210` - DTI Study of the Influence of Physiotherapy on Distribution of BoNT in Spastic Muscle	N/A
Completed	`NCT02073513` - Kinesiotaping the Hand in Cerebral Palsy	N/A
Completed	`NCT00607542` - Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity	Phase 1/Phase 2
Completed	`NCT00702468` - Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis	Phase 3
Active, not recruiting	`NCT04815967` - Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity	Phase 2/Phase 3