Heated Vest for Persons With Spinal Cord Injury
Spinal Cord Injuries
About this trial
This is an interventional other trial for Spinal Cord Injuries focused on measuring Hypothermia, Body Temperature Regulation, Cognition
Eligibility Criteria
Inclusion Criteria:
Subjects with spinal cord injury (SCI) and able-bodied subjects will be recruited according to the following criteria:
- Duration of injury 1 year
- Neurological Level of SCI [C3-T1]; American Spinal Injury Association (ASIA) Impairment Scale (AIS) A & B
Euhydration
- Subjects will be instructed to avoid caffeine and alcohol
- maintain normal salt and water intake
- avoid strenuous exercise for 24 hours prior to study
Exclusion Criteria:
- Known heart, kidney, peripheral vascular or cerebrovascular disease
- High blood pressure
- History of Traumatic Brain Injury (TBI) or diagnosed cognitive impairment
- Untreated thyroid disease
- Diabetes mellitus
- Acute illness or infection
- Dehydration
- Smoking
- Pregnant women
- BMI>30 kg/m2
- Broken, inflamed, or otherwise fragile skin
Sites / Locations
- James J. Peters VA Medical Center, Bronx, NY
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Experimental
Active Comparator
Heated Vest Safety & Comfort (able-bodied subjects)
Heated Vest Efficacy (persons with tetraplegia)
Non-Heated Vest control condition (persons with tetraplegia)
Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation.
Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort.
The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort.