Body Temperature in Persons With Tetraplegia When Exposed to Heat
Core Temperature During Heat Exposure in Persons With Tetraplegia
1 other identifier
observational
21
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 27, 2013
CompletedFirst Posted
Study publicly available on registry
July 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
March 3, 2016
CompletedMarch 3, 2016
February 1, 2016
2.4 years
June 27, 2013
November 24, 2015
February 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Core Body Temperature
To determine the change in core body temperature in the seated position from 79 degrees F for 30 minutes to 95 degrees F for up to 2 hours. Hypotheses: Persons with tetraplegia will have a greater increase in core body temperature than able-bodied (AB) control subjects. Core body temperature in AB persons will be maintained.
2 hours
Secondary Outcomes (1)
Cognitive Performance - Stroop Interference T-Scores
2 hours
Other Outcomes (1)
Sweat Rate
2 hours
Study Arms (2)
Tetraplegia
Persons with spinal cord injury, level of injury C4-T1, American Spinal Injury Association (ASIA) impairment levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.
Control
Age and gender-matched able-bodied controls. Ages 18-65 years old.
Interventions
Heat exposure of 95 degrees F for up to 2 hours.
Eligibility Criteria
10 subjects with tetraplegia (SCI, C4-T1), ages 18-65 years old and 10 age- and gender-matched, able-bodied controls will be accepted for participation.
You may qualify if:
- Between 18 and 65 years of age;
- Duration of injury ≥ 1 year;
- Level of SCI C4-T1;
- Euhydration (Subjects will be instructed to avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to study); and
- Age (± 5 years) and gender matched AB control group.
You may not qualify if:
- Known heart and/or blood vessel disease;
- High blood pressure;
- Kidney disease;
- Diabetes mellitus;
- Acute illness or infection;
- Dehydration;
- Pregnant women;
- Untreated thyroid disease, and
- Broken, inflamed, or otherwise fragile skin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC
The Bronx, New York, 10468, United States
Related Publications (2)
Kumar NS, Bart J, Barton C, Graham ML, Leung PP, Tittley TD, Lee I, Bang C, Bauman WA, Handrakis JP. Core Temperature Lability Predicts Sympathetic Interruption and Cognitive Performance during Heat Exposure in Persons with Spinal Cord Injuries. J Neurotrauma. 2021 Aug 1;38(15):2141-2150. doi: 10.1089/neu.2020.7598. Epub 2021 May 26.
PMID: 33882698DERIVEDHandrakis JP, Ni Guan Z, Nulty JW, Tascione O, Rosado-Rivera D, White D, Bang C, Spungen AM, Bauman WA. Effect of Heat Exposure on Cognition in Persons with Tetraplegia. J Neurotrauma. 2017 Dec 15;34(24):3372-3380. doi: 10.1089/neu.2016.4850. Epub 2017 Aug 16.
PMID: 28462685DERIVED
Biospecimen
Venous blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John P. Handrakis
- Organization
- James J. Peters VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
John P Handrakis, PT, DPT, EdD
Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Health Science Specialist
Study Record Dates
First Submitted
June 27, 2013
First Posted
July 2, 2013
Study Start
May 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 3, 2016
Results First Posted
March 3, 2016
Record last verified: 2016-02