Body Temperature in Persons With Tetraplegia When Exposed to Heat

NCT ID: NCT01890915

Last Updated: 2016-03-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Heat Exposure

Intervention Type OTHER

Heat exposure of 95 degrees F for up to 2 hours.

Control

Age and gender-matched able-bodied controls. Ages 18-65 years old.

Heat Exposure

Intervention Type OTHER

Heat exposure of 95 degrees F for up to 2 hours.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Heat Exposure

Heat exposure of 95 degrees F for up to 2 hours.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

95 degrees F for up to 2 hours.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

James J. Peters Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John Handrakis, PT, DPT, EdD

Research Health Science Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John P Handrakis, PT, DPT, EdD

Role: PRINCIPAL_INVESTIGATOR

Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC

The Bronx, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33882698 (View on PubMed)

Handrakis 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.

Reference Type DERIVED
PMID: 28462685 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HAN-12-04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Therapeutic Normothermia in TBI
NCT06540768 NOT_YET_RECRUITING NA