Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CRS-R (JFK Coma recovery scale-revised)
研究概览
简要总结
The purpose of this study was to determine the effect of stroke on post-stroke level of consciousness through a double-blind, placebo-controlled, randomized study design. And Brain 18F-FDG PET was used to reveal the mechanism of recovery after cerebrolysin administration.
Thirty patients with chronic stroke patients with minimal consciousness (MCS) or vegetative human (VS) level of consciousness disorder in the revised coma recovery scale were enrolled. Thirty patients were randomly divided into a Cerebrolysin group and a placebo group.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke patients
- •Stroke with CT or MRI diagnosis
- •Chronic patients with more than 3 months of stroke onset
- •Patients with vegetative status or minimal consciousness (Coma Recovery Scale -revised: CRS-R)
- •Age: 19 to 90 years old
- •A person who voluntarily consents to the clinical trial in writing by the principal or legal representative
排除标准
- •In case of contraindications, including allergies to cerebrolysin
- •Patients with contraindications to PET
- •Progressive or unstable stroke
- •In case of accompanying serious neurogenic disease
- •Major depressive disorder, schizophrenia, bipolar disorder, dementia, and other serious psychiatric diseases.
- •History of alcohol or other drug addiction within 3 years of onset
- •In case of accompanying serious liver, kidney, heart, or respiratory disease
- •If you have the following medical abnormalities (Total serum bilirubin> 4 mg/dL, alkaline phosphatase> 250 U/L, SGOT/AST> 150 U/L, SGPT/ALT> 150 U/L, or creatinine) > 3.5 mg/dL)
- •In case of having a medical disease that is less than 1 year old
- •During pregnancy or lactation
- •Participating in other therapeutic research
研究组 & 干预措施
Cerebrolysin
干预措施: Cerebrolysin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
CRS-R (JFK Coma recovery scale-revised)
时间窗: up to 11 weeks
It is a test that analyzes a total of six functions of hearing, vision, movement, speech, communication, and arousal by item to determine the improvement in the level of consciousness of patients with decreased consciousness. These items are scored to determine whether they are in a minimally conscious state (MCS).
次要结局
未报告次要终点