N/A
N=17
Heated Vest for Persons With Spinal Cord Injury
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03662308 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in Core Body Temperature (Tcore) — -0.22; -0.46 Degrees Celsius — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heated Vest (Device); Non-Heated Vest (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Core Body Temperature (Tcore) |
-0.22; -0.46 | <0.05 sig |
| PRIMARY Change in Cognitive Performance: WAIS-IV (Wechsler Adult Intelligence Scale-Fourth Edition) |
-0.500; -0.375 | — |
| PRIMARY Change in Cognitive Performance: Delayed Recall |
-0.38; -2.00 | — |
| PRIMARY Change in Cognitive Performance: Stroop |
-2.125; -1.750 | — |
| SECONDARY Change in Thermal Comfort (TC) |
0.031; -1.04; -0.96 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT03662308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.