Body Temperature in Persons With Tetraplegia When Exposed to Heat

Status Completed

Clinical Trial Summary

The deleterious effects of hyperthermia are well appreciated in able-bodied persons. However, the consequences of impaired regulation of normal body temperature on cognitive performance of persons with tetraplegia is not known. This study will provide the preliminary findings necessary for future work to design and explore physical and medical interventions to improve temperature regulation in those with tetraplegia with the goal of improved clinical care, health, and quality of life.

The proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10 controls) will be exposed to 81°F for 40 minutes and then 95° F for up to 2 hours. Physiological as well as psychological processes will be monitored in all subjects during the study for safety and to determine differences in responses to exposure to hot ambient temperatures

Clinical Trial Description

After a cervical spinal cord injury (SCI) the motor, sensory and autonomic deficits cause, among other detriments, a blunted ability to maintain a constant core temperature. Impaired thermoregulation leaves persons with tetraplegia more susceptible to hyperthermia than able-bodied persons (AB). There has been a paucity of work addressing the thermoregulatory responses of persons with SCI to hot ambient temperatures, and even less study addressing the effect of these temperatures on cognitive performance. The goals of this pilot study are: to improve our understanding of the thermoregulatory mechanisms of individuals with tetraplegia when exposed to heat and to determine the effect of impaired thermoregulatory mechanisms on cognitive performance during exposure to 35°C for up to 2 hours. In order to address our goals we have designed a study methodology which consists of comparing the physiological and psychological responses of the two study groups (tetraplegia versus AB controls) from thermoneutral (27°C) to hot (35°C) environments. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01890915
Study type	Observational
Source	James J. Peters Veterans Affairs Medical Center
Contact
Status	Completed
Phase	N/A
Start date	May 2013
Completion date	October 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02574572` - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury	Phase 1
Recruiting	`NCT05941819` - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury	N/A
Completed	`NCT05265377` - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury	N/A
Recruiting	`NCT02331979` - Improving Bladder Function in SCI by Neuromodulation	N/A
Completed	`NCT02777281` - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI	N/A
Recruiting	`NCT02978638` - Electrical Stimulation for Continence After Spinal Cord Injury	N/A
Withdrawn	`NCT02237547` - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT02161913` - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers	N/A
Completed	`NCT02262234` - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study	Phase 1/Phase 2
Completed	`NCT01642901` - Zoledronic Acid in Acute Spinal Cord Injury	Phase 3
Terminated	`NCT02080039` - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury	N/A
Completed	`NCT01884662` - Virtual Walking for Neuropathic Pain in Spinal Cord Injury	N/A
Terminated	`NCT01433159` - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury	Phase 2
Completed	`NCT01471613` - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT02149511` - Longitudinal Morphometric Changes Following SCI
Completed	`NCT01467817` - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)	N/A
Completed	`NCT01086930` - Early Intensive Hand Rehabilitation After Spinal Cord Injury	Phase 3
Terminated	`NCT01005615` - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT01025609` - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Completed	`NCT00663663` - Telephone Intervention for Pain Study (TIPS)	N/A