The Safety and Efficacy of Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage: a Multicenter, Prospective, Randomized, Outcome-blind Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Change in consciousness 12 months after surgery assessed by CRS-R
研究概览
简要总结
Disorders of consciousness (DOC) refers to the persistent loss of consciousness after 28 days in patients with brain injury caused by trauma, stroke, or hypoxia. It includes coma, vegetative state, and minimally conscious state. At present, there is no effective treatment for DOC. Only one RCT study of amantadine has proved that it may be effective for the treatment of DOC. In recent years, more evidence has shown that neuromodulation technology is beneficial to the recovery of DOC. Cervical spinal cord stimulation surgery is a new treatment method for patients with DOC. Electrodes are implanted in the high cervical spinal cord C2-C5. By adjusting different electrical stimulation parameters, it has a wake-promoting effect. In this study, patients were selected into the spinal cord stimulation group and the conventional treatment group according to the wishes of their families. The patients in the spinal cord stimulation group were given 21 days of cervical spinal cord stimulation treatment on the basis of conventional brain rehabilitation. Patients were followed up routinely and completed designated examinations at 12 months to determine the safety and efficacy of cervical spinal cord stimulation therapy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years old
- •Patients with postoperative consciousness disorders after cerebral hemorrhage for more than 28 days
- •CRS-R score meets the MCS diagnosis
- •Signed informed consent.
排除标准
- •Secondary brain injury caused by arteriovenous malformation, cerebral aneurysm, cavernous hemangioma, brain tumor and carbon monoxide poisoning
- •History of previous epileptic seizures
- •Critical condition, unstable intracranial condition, risk of rebleeding
- •Unstable vital signs requiring mechanical ventilation
- •Contraindications for spinal cord surgery
- •Severe sympathetic overactivity syndrome.
结局指标
主要结局
Change in consciousness 12 months after surgery assessed by CRS-R
时间窗: 12 months
The primary efficacy indicator is "change in consciousness recovery 12 months after cervical spinal cord electrical stimulation (assessed by the Coma Recovery Scale - Revised (CRS-R), ranges from 0 to 25, with higher scores mean a better outcome)".
次要结局
- Consciousness recovery 12 months after surgery assessed by GOS-E(12 months)
研究者
Dr. Yong Cao
director
Beijing Tiantan Hospital
