Navigation Brain Stimulation (NBS) for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MEP(motor evoked potential) parameter: motor threshold
研究概览
简要总结
Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's very important to choose the right way of the management of the patient and an appropriate drugs.
There is a large number of the so-called neuroprotective drugs, which were effective in laboratory, but didn't show positive results in clinical studies with using traditional clinical scales scores as a primary outcome measures.
Specialists suggest, that the investigators could receive better results if the investigators change design of the studies, particularly if the investigators select more precise and sensitive method of assessment.
Aim of this study: to determine the role of navigated brain stimulation (NBS) for evaluation of the changes in the motor centers and motor tracts after administration of different cerebroprotective drugs. (The substances won't be compared to each other).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients from 3 to 6 months after ischemic stroke
- •hemispheric infarction
- •paresis from 2 to 4 scores by Medical Research Council Weakness Scale (MRC)
排除标准
- •history of seizures
- •pregnancy, lactation
- •cognitive deficiency (poor compliance)
- •acute renal failure
- •acute hepatic failure
- •oncological history
- •cardiac pacemakers and other metal implants
- •regular intake of any nootropic drugs
- •Modified Ashford Scale scores 3 and more
- •regular intake of anticonvulsants, neuromuscular relaxants
研究组 & 干预措施
cerebrolysin
IV
干预措施: cerebrolysin (Drug)
L-Alpha glycerylphosphorylcholine
IV
干预措施: L-Alpha glycerylphosphorylcholine (Drug)
citicoline
IV and per os
干预措施: citicoline (Drug)
结局指标
主要结局
MEP(motor evoked potential) parameter: motor threshold
时间窗: 2 months
MEP(motor evoked potential) parameter: latency
时间窗: 2 months
MEP(motor evoked potential) parameter: amplitude
时间窗: 2 months
次要结局
- Medical Research Council (MRC) Scale for Muscle Strength scores(2 months)
- Barthel index(2 months)
- Modified Rankin Scale (mRS)(2 months)
- Number of Participants with Adverse Events(2 months)
- Change from Baseline in Alpha waves percentage(2 months)
- Change from Baseline in Beta waves percentage(2 months)
- Change from Baseline in Delta waves percentage(2 months)
- Change from Baseline in Theta waves percentage(2 months)
- Presence of the abnormal epileptiform activity(2 months)