Body Temperature in Persons With Tetraplegia When Exposed to Heat

February 4, 2016 updated by: John Handrakis, PT, DPT, EdD, James J. Peters Veterans Affairs Medical Center

Core Temperature During Heat Exposure in Persons With Tetraplegia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10468
        • Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Heat Exposure
Heat exposure of 95 degrees F for up to 2 hours.
Other Names:
  • 95 degrees F for up to 2 hours.
Control
Age and gender-matched able-bodied controls. Ages 18-65 years old.
Other: Heat Exposure
Heat exposure of 95 degrees F for up to 2 hours.
Other Names:
  • 95 degrees F for up to 2 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Body Temperature
Time Frame: 2 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Performance - Stroop Interference T-Scores
Time Frame: 2 hours
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sweat Rate
Time Frame: 2 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James J. Peters Veterans Affairs Medical Center

Investigators

  • Principal Investigator: John P Handrakis, PT, DPT, EdD, Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (ESTIMATE)

July 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAN-12-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injury

Clinical Trials on Heat Exposure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe