Developing a Feedback-Controlled Heated Vest to Address Thermoregulatory Dysfunction in Persons with Spinal Cord Injury

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Persons with spinal cord injury (SCI), particularly [cervical injuries (tetraplegia]), are unable to effectively regulate core body temperature (Tcore) due to interruption of motor, sensory, and sympathetic pathways. Thus, control of distal extremity vasoconstriction (heat conservation) and shivering thermogenesis (heat production) are impaired, and the ability to maintain a constant Tcore is compromised. Persons with tetraplegia often report “feeling cold,” frequently present with subnormal Tcore (35-36.5°C), and are particularly vulnerable to hypothermia (Tcore<35°C) and associated impairment in cognitive performance, even when exposed to temperatures that are comfortable for able-bodied (AB) individuals. Cool seasonal temperatures have been shown to have a greater adverse effect on personal comfort, activities of daily living (ADLs), and vital daily activities in persons with tetraplegia than that of AB controls. Conversely, a minimal increase in Tcore from subnormal to normothermia, secondary to ambient heat may improve cognitive performance. Interventions addressing the tendency to poikilothermia and enhanced vulnerability to hypothermia in persons with [tetraplegia] are limited. Therefore, exploration of safe and efficacious bioengineering solutions to address the physiological, cognitive, and quality of life (QoL) issues associated with the routine exposure to cool temperatures that persons with [tetraplegia] often encounter is warranted. The goals of this pilot study in persons with [tetraplegia] are: 1) to study the safety and tolerability of a feedback-controlled heated vest and then 2) to study the efficacy of this heated vest to minimize the expected decline in Tcore and associated deterioration of cognitive performance during 2 hours of cool exposure. This single-group (persons with [tetraplegia]), two-condition (heated vest, non-heated vest) prospective study is being proposed to compare the physiological and cognitive responses to controlled cool exposure (18°C) with a prototype heated vest vs. a non-heated vest (control condition). [Eight] subjects with [tetraplegia (C3-T1], AIS A and B) and [eight] AB controls will be recruited for study participation. AB subjects will be observed to ensure the safety of the vest, which will be accomplished by determining the temperatures of the vest and subjective thermal sensation of less than “hot” during a cool condition that will be identical to that to which subjects with SCI will be exposed. Subjects with [tetraplegia] will test the efficacy of the heated vest, i.e. preventing the expected decline in Tcore and cognitive performance and increased thermal comfort. Primary Specific Aim: In a cool thermal chamber (18°C), AB controls will wear the heated vest at maximal setting for 120 minutes in the seated position to determine (1) maximum temperatures of all areas of the interior (user’s side) of the heated vest and (2) subjective comfort of the heated vest (safety testing). Primary Hypotheses: (1) 100% of the interior surface of the vest will have temperatures ≤38°C. (2) 100% of AB controls will report a thermal sensation of only “warm” and not “hot”. (3) 100% of AB controls will not report any areas of concentrated heat, e.g. “hot” spots (Zhang 9-point Thermal Sensation Scale). Secondary Specific Aim: During exposure to a cool environment (18°C) for up to 120 minutes in the seated position, persons with [tetraplegia] will wear the heated vest to determine (1) change in Tcore, (2) change in cognitive performance, and (3) change in thermal comfort (efficacy testing). Secondary Hypotheses: In persons with [tetraplegia] wearing the heated vest compared to the same persons wearing the non-heated vest, it’s expected that (1) 30% of the subjects will have a decline of at least 0.5°C in Tcore compared with 80% in the control condition, (2) 30% of the subjects will demonstrate a decline of at least 1 T-score in at least one of the following measures: Interference of Stroop Color and Word test, Digit Span of Wechsler Adult Intelligence Scale-Fourth Edition, compared with 80% in the control condition, and (3) a greater percentage of subjects reporting increased thermal comfort (Zhang 6-point Comfort Scale).