Relationship Between Magnesium Concentration in Blood and Kognitive Functions After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from National Institutes of Health Stroke Scale at day 28
研究概览
简要总结
Cognitive impairments such as memory impairments, word-finding difficulties, compromised orientation and perception are often observed in stroke patients.
Low serum-mg-concentrations are associated with cognitive impairments in ischemic stroke patients one month after stroke onset. It is not clear, if cognitive impairments after stroke is caused by the mg-deficiency or by the stroke itself. Until now, no studies investigating the relationship between mg-concentration, stroke severity and cognition during treatment course are available. Thus, this study aimed to investigate the relationship between mg-concentration and cognition of stroke patients.
详细描述
Stroke patients admitted to the stroke unit will be included. Initial mg-concentration in serum as well as stroke related measures (National Institutes of Health Stroke Scale, Scandinavian Stroke Scale, modified Rankin Scale) will be ealuated. Moreover, the cognitive abilities of the patient will be assessed within the first three days via the Kölner Neuropsychologische Screening for stroke patients as well as the Mini Mental Status Test.
During stroke rehabilitation mg-level, stroke related measures (NIHSS,SSS,MRS) as well as the cognitive tests (MMST,KöpSS) will be re-assed after 4 weeks, 3 month as well as at study end, which is defined as discharge from the clinic (death, transfer to another hospital without return after 4 weeks, discharge to long-term nursing/ home/hospice).
Attention-network of stroke patients are measeared if the patient undergo a MRi scan.
In this study following questions will be assessed:
- What is the incidence of cognitive impairments in stroke patients?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ischemic/hemmorhagic stroke
- •written consent form
排除标准
- •pre-existing dementia or cognitive impairment before stroke onset
- •pre-existing mental disorder (depression) or present/prior long-term treatment (> 6 months) with psychotropic drugs
- •pre-existing malign tumor disease
- •participation in another clinical trial within the past 30 days
- •pregnancy or breastfeeding
研究组 & 干预措施
Stroke Patients
Ischemic-/hemorragic stroke patients, who admitted on the stroke unit.
干预措施: Kölner Neuropsychologische Screening für Schlaganfall-Patienten (Diagnostic Test)
结局指标
主要结局
Change from National Institutes of Health Stroke Scale at day 28
时间窗: day 28
0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke
Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS)
时间窗: day 3
The score ranges from 0 to 108 points. If all subtest can be performed, a score \<98 points identify an impaired cognition.
Change from National Institutes of Health Stroke Scale at day 3
时间窗: day 3
0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke
Change from National Institutes of Health Stroke Scale at study end
时间窗: up to 6 month
0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke
Lenght of stay
时间窗: up to 6 month
Lenght of stay will be assesse at discharge.
Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at study end
时间窗: up to 6 month
The score ranges from 0 to 108 points. If all subtest can be performed, a score \<98 points identify an impaired cognition.
Serum mg-concentration
时间窗: day 1
This study defines a reference value ranging from 1,8 to 2,53 mg/dl.
Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 28
时间窗: day 28
The score ranges from 0 to 108 points. If all subtest can be performed, a score \<98 points identify an impaired cognition.
Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 72
时间窗: day 72
The score ranges from 0 to 108 points. If all subtest can be performed, a score \<98 points identify an impaired cognition.
Change from Serum mg-concentration from admission at day 28
时间窗: day 28
This study defines a reference value ranging from 1,8 to 2,53 mg/dl.
Change from Serum mg-concentration from admission at day 72
时间窗: day 72
This study defines a reference value ranging from 1,8 to 2,53 mg/dl.
Change from Serum mg-concentration from admission at study end
时间窗: up to 6 month
This study defines a reference value ranging from 1,8 to 2,53 mg/dl.
National Institutes of Health Stroke Scale
时间窗: day 1
0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke
Change from National Institutes of Health Stroke Scale at day 72
时间窗: day 72
0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke
次要结局
- Change from Mini Mental State Test (MMST) at day 72(day 72)
- Modified Rankin Scale (MRS)(day 1)
- Change from Modified Rankin Scale (MRS) at day 3(day 3)
- Change from Scandinavian Stroke Scale (SSS) at day 72(day 72)
- Change from Early Rehabilitation Barthel Index (ERBI) at study end(up to 6 month)
- International Classification of Functioning Disability and Health (ICF) Assessment(day 1)
- Change from Early Functional Abilities (EFA) at day 28(day 28)
- Mini Mental State Test (MMST)(day 3)
- Change from Scandinavian Stroke Scale (SSS) at day 28(day 28)
- Change from Scandinavian Stroke Scale (SSS) at study end(up to 6 month)
- Change from Mini Mental State Test (MMST) at day 28(day 28)
- Change from Mini Mental State Test (MMST) at study end(up to 6 month)
- Change from Modified Rankin Scale (MRS) at day 28(day 28)
- Change from Modified Rankin Scale (MRS) at study end(up to 6 month)
- Change from Early Rehabilitation Barthel Index (ERBI) at day 28(day 28)
- Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 28(day 28)
- Change from Early Functional Abilities (EFA) at day 72(day 72)
- Adverse events and complications(up to 6 month)
- Change from Modified Rankin Scale (MRS) at day 72(day 72)
- Scandinavian Stroke Scale (SSS)(day 1)
- Early Rehabilitation Barthel Index (ERBI)(day 1)
- Change from Early Rehabilitation Barthel Index (ERBI) at day 3(day 3)
- Early Functional Abilities (EFA)(day 1)
- Change from Scandinavian Stroke Scale (SSS) at day 3(day 3)
- Change from Early Rehabilitation Barthel Index (ERBI) at day 72(day 72)
- Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 72(day 72)
- Change from International Classification of Functioning Disability and Health (ICF) Assessment at study end(up to 6 month)
- Change from Early Functional Abilities (EFA) at study end(up to 6 month)