EEG Dynamics Induced by Zolpidem Forecasts Consciousness Evolution in Prolonged Disorders of Consciousness and Quantification of EEG Reactivity Predicts Recovery of Consciousness
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The Coma Recovery Scale-Revised
研究概览
简要总结
The research contains two parts. Part 1: To explore whether EEG responses to zolpidem can assess consciousness circuit integrity and predict the evolution of consciousness in patients with prolonged disorders of consciousness; Part 2: To explore if quantitative EEG reactivity might predict the prognosis of disorders of consciousness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission;
- •time since onset > 4 weeks;
- •no history of neurodegenerative or psychiatric diseases.
排除标准
- •allergic to zolpidem;
- •currently receiving zolpidem or related benzodiazepines;
- •diagnosed with seizure or status epilepticus.
研究组 & 干预措施
Patients with prolonged disorders of consciousness
- age ≥ 18 years;
- presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission;
- time since onset > 4 weeks;
- no history of neurodegenerative or psychiatric diseases.
All patients were administered 10 mg of zolpidem tartrate tablets via a feeding tube and received EEG-reactivity test.
干预措施: Zolpidem Tartrate Tablets (Drug)
Healthy volunteers
Healthy volunteers without any history of autonomic or any other nervous system disorder were included in this study. They were administered 10 mg of zolpidem tartrate tablets orally.
干预措施: Zolpidem Tartrate Tablets (Drug)
结局指标
主要结局
The Coma Recovery Scale-Revised
时间窗: Six months after enrollment
The consciousness was independently assessed using CRS-R six months after enrollment by a trained neurologist blinded to the clinical data. Patients who transitioned from UWS to MCS (UWS-MCS) or to emergence from MCS (EMCS) (UWS-EMCS), from MCS minus to MCS plus (MCS--MCS+) or to EMCS (MCS--EMCS), and from MCS to EMCS (MCS-EMCS) were categorized in the improved consciousness group. The unimproved consciousness was defined as a reduced or unchanged level of consciousness at six months.
次要结局
未报告次要终点