NCT06571032招募中不适用
Evaluation of Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries: A Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CRS-R scores 6 months after the patient's discharge
研究概览
简要总结
The goal of this observational retrospective study is to evaluate the electroencephalography (EEG)'s poficiency in the treatment of neuroelectric stimulation in patients with severe traumatic brain injuries (TBI).
The main questions it aims to answer are:
- Whether EEG of patients with severe TBI will change after they receiving neuroelectrial stimulation? If yes, how does it change?
- How can EEG be used to evaluate the condition of patients with severe TBI?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •7 days after severe traumatic brain injuries (GCS score 3-8);
- •Over 18 years old, regardless of gender;
- •The patient's legal representative is informed and voluntarily signs the consent form.
排除标准
- •Unstable vital signs;
- •History of mental disorders or neurodegenerative diseases;
- •Uncontrolled epilepsy;
- •Severe arrhythmias or patients with implanted cardiac pacemakers;
- •Various conditions that interfere with scalp EEG collection;
- •Pregnant women.
结局指标
主要结局
CRS-R scores 6 months after the patient's discharge
时间窗: 6 months
Using the COMA RECOVERY SCALE-REVISED (CRS-R) to evaluate the condition of the patient 6 months after discharge and the effectiveness of neuroelectrial stimulation. The minimum and maximum values of CRS-R is 0 and 23 and higher scores mean a better outcome.
次要结局
- CRS-R scores during hospitalization(3 months)
研究者
Junfeng Feng
Director of Brain Injury Center
RenJi Hospital
研究点 (1)
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