Intrathecal contrast-enhanced MRI for investigation of cerebrospinal fluid transportation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time-dependent change in signal intensity on brain MRI after intrathecal contrast administration will be analyzed with indicator dilution algorthim that will be optimized using computational fluid dynamic simulations.
研究概览
简要总结
To quantify the distribution and rate of elimination of the contrast agent as assessed by repeated MRI in humans. We will also document any adverse events related to the administration of Gadovist
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients investigated for suspected idiopathic normal pressure hydrocephalus at Umeå University hospital
排除标准
- •Not able to understand instructions needed for informed concent
- •known contradicting allergies
- •Known contraindications for magnetic reconance imaging
- •Renal impairment (as deffined by blood test at admission)
- •Current treatment with anticoagulation medication
- •Low threshold for seizures
- •History of bronchial asthma
- •Previous investigation with gadolinium contrast medium
- •Mini mental state examination (MMS) < 20
结局指标
主要结局
Time-dependent change in signal intensity on brain MRI after intrathecal contrast administration will be analyzed with indicator dilution algorthim that will be optimized using computational fluid dynamic simulations.
Time-dependent change in signal intensity on brain MRI after intrathecal contrast administration will be analyzed with indicator dilution algorthim that will be optimized using computational fluid dynamic simulations.
Registration of possible adverse events related to the intrathecal injection of Gadovist
Registration of possible adverse events related to the intrathecal injection of Gadovist
次要结局
- Comparision between the distribution of the contrast and other MRI-sequences and cerebrospinal fluid dynamic parameters which provides us with information regarding possible driving mechanisms for the distribution.
- Quantified pre-operative glymphatic function will be correlated to clinical improvment after CSF shunting of INPH patients
研究者
Prof Malm, Department of neurology
Scientific
Region Vaesterbotten