Body Temperature in Persons With Tetraplegia When Exposed to Cold
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.
Mild Cognitive Impairment
Drug: Midodrine hydrochloride
|Study Design:||Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
|Official Title:||Core Temperature During Cold Exposure in Persons With Tetraplegia|
- Core body temperature [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]We will test the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) in persons with tetraplegia.
- Cognitive performance [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Cognitive performance will be evaluated as a composite measure consisting of assessments of attention, working memory, processing speed and executive function. We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
No Intervention: No Drug
Tetraplegia: Lesion level T1 and above, ASIA levels A and B, ages 18-68 years. AB Controls: Matched for age and gender. Exposure of up to 2 hours in a cool room.
Experimental: Drug (midodrine)
Persons with tetraplegia who completed Visit 1 (no drug). Participants are administered midodrine hydrochloride (10 mg tablet) by a physician before exposure of up to 2 hours in a cool room. (Visit 2)
Drug: Midodrine hydrochloride
Midodrine hydrochloride is an approved medication used to treat low blood pressure. We are using a standard dose of 10 mg (tablet) only one time to determine if the effects of this drug improve the ability to maintain body core temperature in a cool environment (off-label use). A physician will administer the drug once before the cool thermal challenge in subjects with tetraplegia only(Visit 2)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01822535
|United States, New York|
|Center of Excellence for the Medical Consequences of SCI, JJP VAMC, 7A-13|
|Bronx, New York, United States, 10468|
|Principal Investigator:||John P Handrakis, PT, DPT, EdD||James J Peters VA MC|