EUCTR2021-001453-31-DK进行中（未招募）1 期
Automated pupillometry and NIRS-EEG to detect signatures ofconsciousness in acute brain injury after apomorphine andmethylphenidate stimulation: A placebo-controlled, randomized, cross-overstudy
Copenhagen University Hospital Rigshospitalet0 个研究点目标入组 41 人开始时间: 2021年3月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years.
- •Fluent in Danish or English language
- •Patients with severe acute traumatic or non-traumatic brain injury in a
- •state of vegetative state/unresponsive wakefulness syndrome or
- •minimal consciousness state according to FOUR and SECONDs.
- •Written informed consent for trial participation from next-of-kin.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Recovery of the ability to follow commands clinically prior to
- •enrollment.
- •Pre-existing disorder of consciousness before the onset of brain injury.
- •Pre-existing mental or physical impairments.
- •Deafness, blindness or bilateral eye surgery before the onset of brain
- •Ongoing use of dopamine agonists or antagonists within 6 half-lives of
- •Ongoing or previous use of psychoactive or psychotropic substances 2
- •weeks prior examination or within 6 half-lives of the drug.
- •Clinically unstable patients requiring immediate neurological, medical
- •or surgical management.
- •Relatives' refusal of consent.
研究者
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