Body Temperature in Persons With Tetraplegia When Exposed to Cold

Completed · Phase 4

Conditions studied: Tetraplegia, Hypothermia, Mild Cognitive Impairment

In brief

The ability to maintain normal body core temperature (Tcore = 98.6°F) is impaired in persons with tetraplegia. Despite the known challenges to the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. The aim of this study is to determine if exposure of up to 2 hrs to cool temperatures (64°F) causes body core temperature to decrease in persons with tetraplegia and if that decrease is related to a decrease in mental performance. After sitting in a cool (64°F) room for up to 2 hours the investigators hypotheses are: Hypotheses (1): Tcore of most of the persons with tetraplegia will decline approximately 1.8°F (e.g., 98.6 to 96.8°F) while Tcore of controls will not decline at all; (2) Most of the persons with tetraplegia will show a decline in mental performance (memory or clear-headedness) while only some of AB controls will show a decline. The second aim of this study is to determine if a 10 mg dose of an approved blood pressure raising medicine (midodrine hydrochloride) will (1) reduce the decrease in body core temperature and (2) prevent or delay the decline in mental performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in the same group. Hypotheses (3 \& 4): The changes in blood flow to the skin caused by taking a one-time dose of midodrine will lessen the decline in Tcore and prevent or delay the decline in mental performance compared to the changes in Tcore and mental performance during cool temperature exposure without midodrine in the group with tetraplegia.

Key facts

Study ID

NCT01822535

Run by

James J. Peters Veterans Affairs Medical Center

People needed

30

Starts

2011-07-01

Expected to finish

2015-10-01

Last updated by the study team

2016-03-04

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• (1) Between 18 and 68 years of age;
• (2) Duration of injury ≥ 1 year; (2) Level of SCI C3-T1;
• (3) 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)

You may not qualify if…

• (1) Known coronary heart, kidney, peripheral vascular or cerebral vascular disease;
• (2) High blood pressure;
• (3) Untreated thyroid disease;
• (4) Diabetes mellitus;
• (5) Acute illness or infection;
• (6) Dehydration;
• (7) Known allergies to midodrine hydrochloride;
• (8) Smoking;
• (9) Pregnancy

Where it is running

• Center of Excellence for the Medical Consequences of SCI, JJP VAMC, 7A-13 — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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