Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

July 31, 2021

Study Completion Date

December 31, 2022

Conditions
TetraplegiaHypothermiaMild Cognitive Impairment
Interventions
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 vascular-constricting effects of this drug will help keep warm blood closer to the body's core and improve the ability to maintain Tcore 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).

OTHER

Cool Temperature

Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (BP, HR, Tcore) and tolerance (comfort).

Trial Locations (1)

10468

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

All Listed Sponsors
collaborator

The Craig H. Neilsen Foundation

OTHER

lead

James J. Peters Veterans Affairs Medical Center

FED

NCT02379156 - Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia | Biotech Hunter | Biotech Hunter