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

开发反馈控制加热背心以解决脊髓损伤患者的体温调节功能障碍

• 批准号: 9816585
• 负责人: John P Handrakis
• 金额: --
• 依托单位: JAMES J PETERS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-11-01 至 2021-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9816585
• 关键词: Activities of Daily Living; Address; Adult; Adverse effects; Area; Awareness; Biomedical Engineering; Body Temperature; Cervical spinal cord injury; Clinical; Cognitive; Color; Deterioration; Devices; Digit structure; Distal; Effectiveness; Ensure; Environment; Environmental Wind; Esthesia; Exposure to; Feedback; Feeling; Functional disorder; Goals; Heating; Hot Spot; Hour; Humidity; Impaired cognition; Impairment; Individual; Intelligence; Interruption; Intervention; Investigation; Limb structure; Maintenance; Measures; Medical; Motor; Normal Range; Pathway interactions; Performance; Persons; Physiological; Pilot Projects; Positioning Attribute; Prospective Studies; Quadriplegia; Quality of life; Reporting; Safety; Seasons; Secondary to; Self Care; Sensory; Shivering; Side; Skin Temperature; Social Work; Socialization; Speed; Spinal cord injury; Sunlight; Surface; Temperature; Testing; Thermogenesis; Veterans; Work; cognitive performance; design; efficacy study; efficacy testing; experience; improved; natural hypothermia; novel; prevent; prototype; recruit; response; safety study; safety testing; sound; thoracic vertebra bone structure; vasoconstriction

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).

脊髓损伤 (SCI) 患者，尤其是[颈椎损伤（四肢瘫痪]），无法有效地 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（热量保存）和颤抖生热（热量） 生产）受到损害，并且维持恒定 Tcore 的能力受到损害。 经常报告“感觉寒冷”，经常出现 Tcore 低于正常值 (35-36.5°C)，并且特别脆弱 体温过低（Tcore<35°C）和相关的认知能力障碍，即使暴露在 适合身体健全 (AB) 人士的舒适温度 凉爽的季节性温度。 研究表明，对个人舒适度、日常生活活动 (ADL) 和重要日常生活有更大的不利影响 四肢瘫痪者的活动比离线的 AB 对照者的 Tcore 略有增加。 继发于环境热量的低于正常体温的干预可能会改善认知能力。 解决患有体温过低的人的体温过低倾向和易受低温影响的问题 [四肢瘫痪]因此，探索安全有效的生物工程解决方案来解决该问题是有限的。 与日常接触凉爽相关的生理、认知和生活质量 (QoL) 问题 [四肢瘫痪] 患者经常遇到的温度是有必要的。 这项针对[四肢瘫痪]患者的初步研究的目标是：1) 研究一种药物的安全性和耐受性 反馈控制加热背心，然后 2) 研究这种加热背心的功效，以尽量减少预期的 在 2 小时的冷环境中，Tcore 下降，认知能力下降。 这项单组（[四肢瘫痪]）、两种条件（加热背心、非加热背心）的前瞻性研究是 建议比较受控冷暴露（18°C）与 原型加热背心与非加热背心（对照条件）[八] 受试者[四肢瘫痪（C3-T1]，AIS）。 A 和 B) 和 [8] 个 AB 对照将被招募用于研究参与，以确保 AB 受试者的参与。 背心的安全性，这将通过确定背心的温度和主观 在凉爽条件下低于“热”的热感觉与受试者的感觉相同 SCI 将暴露于[四肢瘫痪]的受试者将测试加热背心的功效，即防止 预计 Tcore 和认知能力会下降，热舒适度会增加。 主要具体目标：在冷热室 (18°C) 中，AB 控制人员将穿着最大程度的加热背心 坐姿设置 120 分钟，以确定 (1) 室内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度（安全测试）。 主要假设： (1) 背心内表面 100% 的温度≤38°C (2) 100%。 AB 对照将仅报告“温暖”而非“热”的热感觉 (3) 100% 的 AB 对照不会报告。 任何热量集中的区域，例如“热点”（Zhang 9 点热感觉量表）。 次要具体目标：坐着暴露于凉爽环境 (18°C) 长达 120 分钟 位置，患有[四肢瘫痪]的人将穿着加热背心以确定（1）Tcore的变化，（2） 认知表现，以及（3）热舒适度的变化（功效测试）。 次要假设：在穿着加热背心的[四肢瘫痪]患者中与同一个人进行比较 穿着非加热背心时，预计 (1) 30% 的受试者的体温会下降至少 0.5°C Tcore 与对照条件下的 80% 相比，(2) 30% 的受试者将表现出至少下降 1 T 分数至少在以下一项测量中获得：Stroop 颜色和单词测试的干扰、数字跨度 韦克斯勒成人智力量表第四版，与对照条件下的 80% 相比，以及 (3) 更大 报告热舒适度增加的受试者百分比（Zhang 6 点舒适量表）。