NCT04745884终止不适用
Early Non-invasive Detection of Progression of Mass Effect From Unilateral Brain Lesions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Functional Outcome
研究概览
简要总结
The purpose of this research is to gather information on the safety and effectiveness of the Brain4Care device for measuring intracranial pressure without invasive procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with non-traumatic hemispheric brain lesions deemed at risk for progression of mass effect and possible subfalcine and/or uncal herniation.
- •Patients admitted the Neuroscience ICU for serial neurological monitoring.
- •Patients whose care is not expected to include immediate surgical decompression.
排除标准
- •Patients under the age of
- •Patients who are unable to provide consent due to neurologic deficit and does not have a surrogate decision maker available to provide consent.
- •Known or suspected Pregnancy
- •Adults with cranial defects or that have undergone craniectomy
研究组 & 干预措施
Monitoring
Experimental
Imaging guided by monitoring results
干预措施: Non-invasive bilateral monitoring of ICP waveform (Device)
结局指标
主要结局
Functional Outcome
时间窗: 3 months
Functional outcome was assessed using the Modified Rankin Scale (mRS) which assesses functional outcomes in patients recovering from strokes. It consists of a 7-point ordinal scale ranging from 0 to 6 where 0=no symptoms and 6=dead with higher scores indicating a worse functional outcome.
次要结局
- Imaging Utilization(within ICU admission)
研究者
Alejandro Rabinstein
Principal Investigator
Mayo Clinic
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Detection of Cerebral Ischemia With a Noninvasive Neurometabolic Optical MonitorTraumatic Brain InjuryIschemic StrokeIntracerebral HemorrhageAcute Anoxic EncephalopathySubarachnoid HemorrhageNCT02983786University of Pennsylvania29
招募中
不适用
Developing a New EEG Method for the Early Diagnosis of DementiaDementiaNCT02426398Sheffield Teaching Hospitals NHS Foundation Trust128
Unknown
不适用
Study of Bedside EEG to Evaluate Brain Injury in Premature NewbornsSeizuresCerebral PalsyBrain InjuryNCT00516334Brigham and Women's Hospital100
已完成
4 期
Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated MalariaMalariaNCT00978172Mepha Ltd.220
撤回
不适用
TMS-EEG for Cortical ExcitabilityAcquired Brain InjuryTraumatic Brain InjuryStrokeHealthyNCT05472363Mayo Clinic