Heated Vest for Persons With Spinal Cord Injury
Completed · Not applicable
Conditions studied: Spinal Cord Injuries
In brief
Persons with higher levels of spinal cord injury (above the 2nd thoracic vertebrae; tetraplegia) are unable to maintain normal core body temperature (Tcore) when exposed to cool environments. In persons with tetraplegia, even limited exposure to cool temperatures may cause Tcore to approach hypothermic values and impair cognitive performance. Conversely, an increase in Tcore from subnormal to normal range may improve cognitive performance. Prior work has shown that cool seasonal temperatures have an adverse effect on personal comfort and the ability to perform vital daily activities of self-care in persons with tetraplegia. Interventions that address the vulnerability to hypothermia are limited. A self-regulating heated vest designed specifically for persons with tetraplegia is a novel and promising strategy to address this problem. By more effectively maintaining Tcore, the vest can decrease the adverse impact of cool temperatures on comfort, quality of life, and performance of vital daily tasks for Veterans with tetraplegia during the cooler seasons.
Key facts
- Study ID
- NCT03662308
- Run by
- VA Office of Research and Development
- People needed
- 17
- Starts
- 2020-02-25
- Expected to finish
- 2022-10-31
- Last updated by the study team
- 2024-05-06
Who can join
Age: 18 and older, up to 68. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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