Body Temperature in Persons With Tetraplegia When Exposed to Heat

Spinal Cord Injury Clinical Trial

Official title:

Core Temperature During Heat Exposure in Persons With Tetraplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890915
• Other study ID #: HAN-12-04
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: February 4, 2016
• Start date: May 2013
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Between 18 and 65 years of age;

2. Duration of injury = 1 year;

3. Level of SCI C4-T1;

4. 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

5. Age (± 5 years) and gender matched AB control group.

Exclusion Criteria:

1. Known heart and/or blood vessel disease;

2. High blood pressure;

3. Kidney disease;

4. Diabetes mellitus;

5. Acute illness or infection;

6. Dehydration;

7. Pregnant women;

8. Untreated thyroid disease, and

9. Broken, inflamed, or otherwise fragile skin.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Heat Exposure
Heat exposure of 95 degrees F for up to 2 hours.

Locations

Country	Name	City	State
United States	Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sweat Rate	To determine the change in sweat rate using QSweat methodology (WR TestWorks) from 30 minutes at 79 degrees F compared to after up to 2 hours at 95 degrees F. Sweat collection capsules will be placed on the left lateral anterior shoulder, volar aspect of the distal forearm, proximal anterior thigh, and mid-lateral calf (dermatomes C5, T1, L3, L5) for measurement of sweat rate. Hypothesis: Persons with tetraplegia compared with AB will have less of a percent change in average sweat rate after heat exposure.	2 hours	Yes
Primary	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	Yes
Secondary	Cognitive Performance - Stroop Interference T-Scores	To determine the change in cognitive performance as measured by the Stroop Color and Word Interference T-Scores, measured after 30 min at 79 degrees F and after up to 2 hours at 95 degrees F. Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance. Hypothesis: Persons with tetraplegia compared with AB will have a greater change in cognitive performance from baseline (79 degrees) to warm exposure (95 degrees).	2 hours	Yes