The Safety and Efficacy of Median Nerve Electrical Stimulation for Improving Neurological Function Prognosis in Patients With Cardiac Arrest: A Multicenter, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The proportion of patients with a CPC score of 1-2
研究概览
简要总结
Median nerve stimulation (MNS), a non-invasive brain stimulation technique, has been widely adopted in clinical arousal therapies and multiple clinical investigations have attested to the efficacy of this technique; nevertheless, evidence concerning the application of MNS in improving the neurological prognosis of patients with return of spontaneous circulation (ROSC) following cardiac arrest (CA) remains scarce. The current study endeavors to assess the safety and efficacy of MNS treatment in enhancing the neurological prognosis of CA patients after ROSC and it is designed as a multicenter, prospective, randomized controlled trial with an estimated sample size of 400 patients. Eligible patients will be randomly allocated in a 1:1 ratio to either receive MNS treatment or sham stimulation treatment for 8 hours per day for 14 consecutive days and the primary outcome measure is the proportion of patients in each group with a Cerebral Performance Category (CPC) score ranging from 1 to 2, 6 months after randomization, which will help to determine the effectiveness of MNS in providing neuroprotection for patients with ROSC after CA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Age ≥ 18 years old.
- •Hemodynamics remains continuously stable for ≥ 7 days.
- •There is still a lack of purposeful movements after the return of spontaneous circulation following cardiopulmonary resuscitation.
- •Advanced life support is provided within 6 hours after the return of spontaneous circulation (ROSC).
排除标准
- •Patients with hemodynamic instability.
- •Pregnant patients.
- •Those who have abnormal anatomical structures on the median nerve conduction pathway and are unable to receive electrical stimulation.
- •Patients with a confirmed history of epilepsy before admission or during hospitalization.
- •Patients with severe arrhythmia or those who have pacemakers implanted.
- •Patients whose family members do not agree to their enrollment in the study.
结局指标
主要结局
The proportion of patients with a CPC score of 1-2
时间窗: 180 days
The primary outcome is the proportion of patients with a score of 1-2 at 180 days after randomization in each group. Favorable: 1 means full recovery or mild disability; 2 means moderate disability but independent in activities of daily living (ADLs). Unfavorable: 3 means severe disability-Dependent in ADLs; 4 means persistent vegetive state; 5 means Death.
次要结局
未报告次要终点
研究者
Tang Ziren
Professor
Capital Medical University
