Effect of a Novel Cooling Device on Brain Temperature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Brain Temperature
研究概览
简要总结
The objective of this study was to clarify whether neck cooling can be used to non-invasively lower brain temperature in healthy adults.
详细描述
Healthy adults were randomized to undergo an intervention in which either cold or body-temperature water was circulated through an adhesive wrap applied to the front of their necks, overlying the carotid arteries, for 120 minutes. After their first intervention, subjects crossed over (i.e., cold went to body-temperature, and vice-versa) on a separate day. Brain temperature was measured in one-minute intervals using MR thermometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-65 years
排除标准
- •Pregnancy
- •Contraindications to MRI (e.g. claustrophobia, metallic implants, etc.)
- •Signs of ulcerations, burns, hives or rash where the neck wrap is applied
- •History of Raynaud's disease, venous or arterial occlusive disease (e.g. carotid stenosis), cryoprecipitation disorders (e.g. cryoglobulinemia) and pernio (also known as chilblains)
研究组 & 干预措施
Cold circulated water
Cold water circulated through an adhesive wrap applied to the front of the neck.
干预措施: Cold circulated water (Device)
Body-temperature circulated water
Body-temperature water circulated through an adhesive wrap applied to the front of the neck.
干预措施: Body-temperature circulated water (Device)
结局指标
主要结局
Change in Brain Temperature
时间窗: 60 minutes
During each intervention, core brain temperature was measured non-invasively, in one-minute increments, using MR thermometry. The change in brain temperature was calculated as the difference of differences between the cold and body-temperature interventions, after 1 hour.
次要结局
- Diastolic Blood Pressure(120 minutes)
- Heart Rate(120 minutes)
- Modified Bedside Shivering Assessment(120 minutes)
- Systolic Blood Pressure(120 minutes)
研究者
Adam Sprouse Blum
Assistant Professor of Neurological Sciences
University of Vermont