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

脊髓损伤（SCI）患者，特别是[颈椎损伤（四肢瘫痪）]， 由于运动、感觉和交感神经通路的中断而调节核心体温（Tcore）。 因此，控制远端肢体血管收缩（热保存）和寒战产热（热 生产）受到损害，并且维持恒定Tcore的能力受到损害。四肢瘫痪者 经常报告“感觉冷”，经常出现Tcore低于正常值（35-36.5°C），并且特别脆弱 低体温（Tcore<35°C）和相关的认知功能障碍，即使暴露于 适合身体健全（AB）的人的温度。凉爽的季节性温度 显示对个人舒适度、日常生活活动（ADL）和日常生活重要性有更大的不利影响 活动的人与四肢瘫痪比AB对照组。相反，Tcore从 低于正常体温，继发于环境热可能会改善认知能力。干预措施 解决有以下情况的人的变温倾向和对体温过低的脆弱性增加： [四肢瘫痪]是有限的。因此，探索安全有效的生物工程解决方案来解决 与常规暴露于冷空气相关的生理、认知和生活质量（QoL）问题 经常遇到的温度[四肢瘫痪]是有道理的。 这项在[四肢瘫痪]患者中进行的初步研究的目的是：1）研究 反馈控制加热背心，然后2）研究这种加热背心的功效，以最大限度地减少预期的 在2小时的冷暴露期间，Tcore下降和相关的认知表现恶化。 这项单组（四肢瘫痪患者）、双条件（加热背心、非加热背心）前瞻性研究 被提议比较生理和认知反应，以控制冷暴露（18°C）与 原型加热背心与非加热背心（对照条件）。[8]例[四肢瘫痪（C3-T1）]受试者，AIS A和B）和[八名] AB对照将被招募参与研究。将观察AB受试者，以确保 背心的安全性，这将通过确定背心的温度和主观温度来实现。 在凉爽条件下，低于“热”的热感觉将与患有 SCI将被曝光。[四肢瘫痪]受试者将测试加热背心的功效，即防止 Tcore和认知性能的预期下降以及热舒适性的增加。 主要特定目标：在凉爽的热室（18°C）中，AB对照将在最大温度下穿着加热背心 在就座位置设置120分钟，以确定（1） 加热背心的内部（用户侧）和（2）加热背心的主观舒适度（安全测试）。 主要假设：（1）背心内表面100%的温度≤38°C。(2)100%的 AB对照将报告仅“温暖”而非“热”的热感觉。(3)100%的AB质控品不会报告 任何集中热量的区域，例如“热点”（Zhang 9点热感觉量表）。 次要特定目的：在暴露于凉爽环境（18°C）长达120分钟的过程中， 位置，[四肢瘫痪]的人将穿着加热背心，以确定（1）Tcore的变化，（2） 认知性能和（3）热舒适性的变化（功效测试）。 次要假设：在[四肢瘫痪]患者中，穿着加热背心的患者与相同患者相比 穿着不加热的背心，预计（1）30%的受试者将有至少0.5°C的下降， 与对照条件下的80%相比，（2）30%的受试者将表现出至少 在以下至少一项测量中获得1个T分数：Stroop颜色和单词干扰测试， 韦氏成人智力量表第四版，与对照组的80%相比，（3）更大的 报告热舒适度增加的受试者百分比（Zhang 6点舒适度量表）。

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).