Scientific Research and Development of Innovative Evidence Based Non-invasive Brain Diagnostic and Monitoring Solutions for Neurological and Traumatic Brain Injury Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of participants with the results of noninvasive intracranial pressure measurement (with Vittamed 205 aICP meter) within clinically acceptable 4 mm Hg difference from invasively measured CSF pressure.
研究概览
简要总结
The aim of the study is to evaluate accuracy and precision of non-invasive intracranial pressure measurement device (Vittamed 205) for selected patients compared with cerebrospinal fluid pressure measured during lumbar puncture
详细描述
Non-invasive intracranial pressure (ICP) measurements with Vittamed 205 aICP meter will be compared to simultaneous cerebrospinal fluid (CSF) pressure measurements during lumbar puncture. Measures of pressure in mmHg will be compared. These measurements will be compared in chronic daily headache, normal pressure hydrocephalus and multiple sclerosis patients groups. For stroke patients noninvasive measurements will be compared with cerebral lesion in brain MRI/CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic daily headache with suspected idiopathic intracranial hypertension
- •Diagnosed of suspected multiple sclerosis (MS)
- •Intracranial hemorrhage/ stroke
排除标准
- •Patient not able to understand information about the trial
- •Uncooperative patient
- •Intracranial hemorrhage volume <20 or >40ml
- •Stroke area larger than 1/3 of the middle cerebral artery
结局指标
主要结局
Number of participants with the results of noninvasive intracranial pressure measurement (with Vittamed 205 aICP meter) within clinically acceptable 4 mm Hg difference from invasively measured CSF pressure.
时间窗: Simultaneous noninvasive ICP and CSF pressure measurements. All measurements will be collected within 20 months until 31 December 2014.
Brain MRI/CT data will be used to compare ocular nerve sheath diameter (in mm) and stroke/ intracerebral hemorrhage volume (in cubic cm) with CSF pressure and non-invasive ICP.
次要结局
未报告次要终点
研究者
Kestutis Petrikonis
M.D., PhD, Associated professor
Lithuanian University of Health Sciences