NL-OMON55551招募中2 期
on-invasive vagus nerve stimulation in acute ischemic stroke. - NOVIS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- Ischemic stroke
- •- NIHSS >=1
- •- Perfusion deficit on the admission CTP scan; the penumbra must comprise at
- •least 1/3 of the total ischemic area (ischemic core and penumbra)
- •- The infarct has to comprise the supratentorial region
- •- Treatment has to start <12 hours after stroke onset
- •- Patients or their representatives need to give their informed consent
排除标准
- •- Age below 18
- •- A life expectancy of less than three months
- •- mRS >2 prior to admission
- •- Contra-indication for contrast CT
- •- Contra-indications for VNS:
- •-> An active implantable medical device such as a pacemaker, deep brain
- •stimulator, or any implanted electronic device
- •-> Symptomatic stenosis or dissection of the carotid artery (in these patients
- •the other side will be stimulated unless a significant stenosis or dissection
- •on the other side is present as well)
- •-> Structural abnormality e.g. lymphadenopathy, previous surgery or abnormal
- •anatomy (in these patients the other side will be stimulated)
- •-> Metal cervical spine hardware or metallic implant near the stimulation site
- •-> Cervical vagotomy (in these patients the other side will be stimulated)
- •-> Pregnancy
研究者
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