NCT02976168已完成不适用
Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in cognitive test battery score
研究概览
简要总结
The aim of the study is to understand the relationship between intracranial pressure regulation, cerebral tissue oxygenation and cognitive functioning. More specifically, the study tests the hypothesis that head down tilt will increase intracranial pressure (not measured in this study, but demonstrated in previous studies), will induce venous congestion and facial swelling, decrease intracranial tissue oxygenation and hamper brain functioning. The objectives of the study therefore are to assess young healthy people during head-down tilt (HDT), and to assess cognitive brain functioning, cerebral tissue oxygenation (non-invasively), frontal skin thickness, cerebral perfusion and neuronal functioning via event-related potentials.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Physically and mentally healthy male test subjects that are able and declare in writing their willingness to participate in the entire study and successfully passed the psychological and medical screening
- •Aged between 18-55 years old with a Body Mass Index (BMI) of 20-28 kg/m2, weight between 65-100 kg, and a height between 158-195 cm
- •Demonstrable medical insurance and official certificate of absence of criminal record
排除标准
- •Inability to sleep on the back
- •Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)
- •Smoking within the past 6 months prior to study commencement
- •Migraine or other chronic head aches
- •Previous psychiatric illness
- •Subjects suffering from weak concentration
- •History of psychological or central nervous disorders
- •Hiatus hernia
- •Gastro-oesophageal reflux
- •Diabetes mellitus
- •Pronounced orthostatic intolerance (< 10 min standing)
- •Kidney disorder: deviations from normal values for creatinine in plasma. (Normal value: Creatinine < 1.20 mg/dl)
- •Thyroid gland disorder: deviations from normal values for thyroid stimulating Hormone (TSH) in plasma. (Normal range: TSH 0.55-4.80 mUnits/l)
- •Anaemia: Hb under normal values (Normal values of Hb for men: 13.5-17.5 g/l)
- •Elevated risk of thrombosis
- •High likelihood of coagulopathy assessed by a clinical standard questionnaire
- •Chronic back complaints
- •History of lumbar surgery
- •History of lumbar spine trauma
- •Motor or sensory deficits as assessed by neurological examination
- •Contraindications against MRI
- •Imprisoned at the time of the study
- •Taking medications that may impair cognitive function, autonomic function or any of the study procedures
- •Ophthalmological conditions including glaucoma, retinopathy, severe cataracts, eye trauma or implants
- •Any other medical condition that the investigators consider a contraindication to the study procedures that would make it unsafe or confound the measurements.
结局指标
主要结局
Change in cognitive test battery score
时间窗: Twice at baseline, and 30 minutes and 20 hours after starting the intervention
The test battery includes sensomotoric speed, psychomotor vigilance, visual analysis of items, abstract thinking and mathematical processing
次要结局
- Change in total sleep time(from 22:00 until 6:00 in all nights)
- Change in mid cerebral artery blood flow velocity(Twice at baseline, and 10 minutes and 19 hours after starting the intervention)
- Magnetic resonance Imaging: Change in resting state functional MRI (fMRI)(Once at baseline, and 2 and 19 hours after starting the intervention)
- Change in P-300(Twice at baseline, and 30 minutes and 20 hours after starting the intervention)
- Magnetic resonance Imaging: Change in fMRI Response to decision task(Once at baseline, and 2 and 19 hours after starting the intervention)
- Change in cerebral tissue oxygenation(Twice at baseline, and 10 minutes and 19 hours after starting the intervention)
- Magnetic resonance Imaging: Change in cerebral blood flow(Once at baseline, and 2 and 19 hours after starting the intervention)
- Change in frontal vein filling(Once at baseline, and 10 minutes and 19 hours after starting the intervention)
- Change in jugular vein filling(Once at baseline, and 10 minutes and 19 hours after starting the intervention)
- Change in sleep effectiveness(over the entire intervention night)
研究者
研究点 (2)
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