Effect of Cerebrolysin on Early Rehabilitation After Ischemic Stroke at the Department of Vascular Neurology and Intensive Neurological Therapy (KOVNINT), University Medical Centre Ljubljana
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 90-day Action Research Arm Test (ARAT) Score change
研究概览
简要总结
The study evaluates the effect and safety of Cerebrolysin administered during early rehabilitation in patients with moderate neurological impairment after acute ischemic stroke, conducted at the Department of Vascular Neurology and Intensive Neurological Therapy, UMC Ljubljana.
详细描述
Cerebrolysin is a neuropeptide preparation from porcine brain in an aqueous solution. The composition of 1 ml of the solution contains 215.2 mg of a low molecular weight fraction of polypeptides extracted from porcine brain (Cerebrolysin concentrate), which corresponds to at least 5.8 mg of peptide nitrogen (15%) and free amino acids (85%).
Cerebrolysin has been registered for many years for the treatment of cerebrovascular and neurodegenerative diseases, as well as traumatic brain injuries worldwide. Since the first approval, the treatment of ischemic stroke (IS) has progressed and new treatment concepts have been developed. In addition, the treatment of IS with Cerebrolysin has developed with different time windows, doses and duration of treatment. The main objective of this study is to determine the effectiveness of Cerebrolysin in early rehabilitation as an adjunct to standard treatment in a group of patients with moderate to severe neurological impairment after acute IS in specific KOVNINT conditions.
All patients will receive acute IS care according to local standards of care, which will not be changed or influenced by the study in any way. To assess the safety and efficacy of Cerebrolysin in practice at KOVNINT, the outcome of patients treated with Cerebrolysin will be compared to patients in the control group who will not receive Cerebrolysin.
The reason for conducting the study is to determine the effectiveness of Cerebrolysin treatment in patients with moderate to severe neurological deficits after acute IS at KOVNINT and to assess the impact of these parameters on the outcome of treatment, especially the effect on neurological impairment at discharge and 90 days after IS.
The aim of this study is to observe the safety and efficacy of Cerebrolysin in patients with moderate to severe neurological impairment after acute IS in the specific KOVNINT conditions. We will conduct an analysis of the use of Cerebrolysin as an adjunct to standard treatment and evaluate its efficacy in the early phase of IS, defined by neurological impairment at discharge and 90 days after IS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being able to perform ARAT test Signed informed consent
- •Both sexes, age not specified
- •Acute ischemic stroke confirmed by imaging
- •NIHSS score 6-12
- •No prior stroke or disability (mRS 0 before stroke)
排除标准
- •Not being able to perform ARAT test
- •Previous stroke or disability (mRS > 0)
- •The patient unable to understand instructions
研究组 & 干预措施
Arm 1: Cerebrolysin Group
The patients in Arm 1 will be treated with cerebrolysin and standard treatment.
干预措施: Cerebrolysin treatment (Drug)
Arm 1: Cerebrolysin Group
The patients in Arm 1 will be treated with cerebrolysin and standard treatment.
干预措施: Standard treatment (including neurorehabilitation) of acute ischemic stroke (Other)
Arm 2: Standard treatment only Group
The patients in Arm 2 will receive standard treatment only.
干预措施: Standard treatment (including neurorehabilitation) of acute ischemic stroke (Other)
结局指标
主要结局
90-day Action Research Arm Test (ARAT) Score change
时间窗: 90 days post-stroke
A standardized test after stroke to measure the function of the upper limb. Range of scores: 0-57, with higher scores meaning a better outcome.
次要结局
- Montreal Cognitive Assessment (MoCA) 90 days(90 days)
- The De Morton Mobility Index (DEMMI) Score 90 days(90 days)
- National Institute of Health Stroke Scale (NIHSS) at discharge and 90 days(90 days)
- Extended Barthel index (EBI) 90 days post-stroke(90 days)
- Modified Rankin Score (mRS) at day 90(90 days)
研究者
Matija Zupan
neurologist, MD, PhD
University Medical Centre Ljubljana