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

患有脊髓损伤(SCI)的人，特别是[颈椎损伤(四肢瘫痪])，无法有效地 调节核心体温(Tcore)，因为运动、感觉和交感神经通路中断。 因此，控制远端血管收缩(热保存)和颤抖生热(热 生产)受到损害，保持恒定Tcore的能力受到损害。四肢瘫痪患者 经常报告“感觉冷”，经常出现不正常的Tcore(35-36.5°C)，特别容易受到伤害 与体温过低(Tcore&lt；35°C)和相关的认知能力损害有关，即使暴露在 对于身体健全(AB)的人来说，舒适的温度。凉爽的季节温度一直是 显示出对个人舒适度、日常生活能力(ADL)和日常生活至关重要的更大不利影响 四肢瘫痪患者的活动明显高于AB对照组。相反，Tcore的最小增幅来自 低于正常到常温，继发于环境高温可能会改善认知能力。干预措施 应对患者体温过低的倾向和对低温的易感性 [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 与常规降温相关的生理、认知和生活质量(QOL)问题 患有四肢瘫痪的人经常遇到的温度是有保证的。 这项针对四肢瘫痪患者的先导性研究的目标是：1)研究阿司匹林的安全性和耐受性 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 在2小时的凉爽暴露中，Tcore的下降和相关的认知表现的恶化。 这项单组(四肢瘫痪患者)、两种情况(加热背心、非加热背心)的前瞻性研究是 建议将受控冷暴露(18°C)的生理和认知反应与 加热背心原型与非加热背心(控制条件)。[8][四肢瘫痪(C3-T1)，AIS]受试者 A和B)和[8]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判断来实现 在凉爽的条件下不太热的感觉，这将与受试者相同 SCI将会被曝光。患有[四肢瘫痪]的受试者将测试加热背心的效果，即防止 预计Tcore和认知性能会下降，热舒适性会增加。 主要特定目标：在凉爽的热室(18°C)中，AB控制组将最大限度地穿着加热背心 在座椅位置设置120分钟，以确定(1)所有区域的最高温度 加热背心的内部(用户侧)和(2)加热背心的主观舒适性(安全测试)。 基本假设：(1)背心内表面的温度将为≤38°C。(2)100% AB控件将报告只有“热”而不是“热”的热感。(3)100%AB控件不报告 任何热度集中的区域，例如“热点”区域(张9分热感评分)。 次要目标：在凉爽的环境中(18°C)坐在座位上长达120分钟 体位，四肢瘫痪患者将穿上加热背心，以确定(1)Tcore的变化，(2)Tcore的变化 认知表现，以及(3)热舒适性的变化(功效测试)。 第二个假设：与同样的人相比，患有[四肢瘫痪]的人穿着加温背心 穿着非加热背心，预计(1)30%的受试者在 与控制条件下的80%相比，(2)30%的受试者将表现出至少下降 在下列测量中至少有一项的T分数：Stroop颜色和单词测试的干扰，数字跨度 韦氏成人智力量表-第四版，与对照组的80%相比，(3)更高 报告热舒适性增加的受试者百分比(张6分舒适量表)。

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).