Magnesium and Cognition After Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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? Are there differences between ischemic and hemorrhagic stroke patients? Are there age and/or gender differences? Are there differences regarding the mg-concentration at admission in comparison to the follow-up (week 4 after admission, 3 month after admission) and between patients with/without cognitive impairments? Is there a correlation between the mg-concentration and the stroke severity? Is there a correlation between the scores of the different cognitive tests (MMST and KöpSS)? Is there an association between the stroke severity, the cognitive impairments (KöpSS) and the neuronal attention network?

Official Title
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Relationship Between Magnesium Concentration in Blood and Kognitive Functions After Stroke

Conditions
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Stroke, Cognition, Magnesium, Neurologic Disorder

Intervention / Treatment
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* Diagnostic Test: Kölner Neuropsychologische Screening für Schlaganfall-Patienten


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic/hemmorhagic stroke written consent form Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke Patients<br>Ischemic-/hemorragic stroke patients, who admitted on the stroke unit. | Diagnostic Test: Kölner Neuropsychologische Screening für Schlaganfall-Patienten<br>* The cognitive state of the patient is measure by the Kölner Neuropsychologische Screening (KöpSS) and by the Mini Mental Status Test (MMST). The MMST is a popular often used test, which makes comparisons to other international studies possible. However, even though this test was specifically designed for stroke patients, it has a limited sensibility. Thus the KöpSS is being used as an additional test demonstrating satisfactory sensibility and specificity. It is suitable for acute and subacute strokes and covers all stroke relevant domains.<br>* Other names: KöpSS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum mg-concentration | This study defines a reference value ranging from 1,8 to 2,53 mg/dl. | day 1 | 
| Change from Serum mg-concentration from admission at day 28 | This study defines a reference value ranging from 1,8 to 2,53 mg/dl. | day 28 | 
| Change from Serum mg-concentration from admission at day 72 | This study defines a reference value ranging from 1,8 to 2,53 mg/dl. | day 72 | 
| Change from Serum mg-concentration from admission at study end | This study defines a reference value ranging from 1,8 to 2,53 mg/dl. | up to 6 month | 
| Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) | The score ranges from 0 to 108 points. If all subtest can be performed, a score <98 points identify an impaired cognition. | day 3 | 
| Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 28 | The score ranges from 0 to 108 points. If all subtest can be performed, a score <98 points identify an impaired cognition. | day 28 | 
| Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 72 | The score ranges from 0 to 108 points. If all subtest can be performed, a score <98 points identify an impaired cognition. | day 72 | 
| Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at study end | The score ranges from 0 to 108 points. If all subtest can be performed, a score <98 points identify an impaired cognition. | up to 6 month | 
| National Institutes of Health Stroke Scale | 0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke | day 1 | 
| Change from National Institutes of Health Stroke Scale at day 3 | 0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke | day 3 | 
| Change from National Institutes of Health Stroke Scale at day 28 | 0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke | day 28 | 
| Change from National Institutes of Health Stroke Scale at day 72 | 0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke | day 72 | 
| Change from National Institutes of Health Stroke Scale at study end | 0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke; ≥25 points: very severe stroke | up to 6 month | 
| Lenght of stay | Lenght of stay will be assesse at discharge. | up to 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental State Test (MMST) | 30 - 28 points no dementia; 27 - 25 points mild cognitive decline; 24 - 18 points mild dementia; 17 - 10 points moderate dementia; < 10 points severe dementia | day 3 | 
| Change from Mini Mental State Test (MMST) at day 28 | 30 - 28 points no dementia; 27 - 25 points mild cognitive decline; 24 - 18 points mild dementia; 17 - 10 points moderate dementia; < 10 points severe dementia | day 28 | 
| Change from Mini Mental State Test (MMST) at day 72 | 30 - 28 points no dementia; 27 - 25 points mild cognitive decline; 24 - 18 points mild dementia; 17 - 10 points moderate dementia; < 10 points severe dementia | day 72 | 
| Change from Mini Mental State Test (MMST) at study end | 30 - 28 points no dementia; 27 - 25 points mild cognitive decline; 24 - 18 points mild dementia; 17 - 10 points moderate dementia; < 10 points severe dementia | up to 6 month | 
| Modified Rankin Scale (MRS) | 0 - No symptoms; 1 - No significant disability. Able to carry out all usual activities, despite some symptoms; 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 - Moderate disability. Requires some help, but able to walk unassisted; 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 - Dead. | day 1 | 
| Change from Modified Rankin Scale (MRS) at day 3 | 0 - No symptoms; 1 - No significant disability. Able to carry out all usual activities, despite some symptoms; 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 - Moderate disability. Requires some help, but able to walk unassisted; 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 - Dead. | day 3 | 
| Change from Modified Rankin Scale (MRS) at day 28 | 0 - No symptoms; 1 - No significant disability. Able to carry out all usual activities, despite some symptoms; 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 - Moderate disability. Requires some help, but able to walk unassisted; 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 - Dead. | day 28 | 
| Change from Modified Rankin Scale (MRS) at day 72 | 0 - No symptoms; 1 - No significant disability. Able to carry out all usual activities, despite some symptoms; 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 - Moderate disability. Requires some help, but able to walk unassisted; 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 - Dead. | day 72 | 
| Change from Modified Rankin Scale (MRS) at study end | 0 - No symptoms; 1 - No significant disability. Able to carry out all usual activities, despite some symptoms; 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 - Moderate disability. Requires some help, but able to walk unassisted; 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 - Dead. | up to 6 month | 
| Scandinavian Stroke Scale (SSS) | Sum score range from 0 to 58 in the edited version,with 0 indicating severe neurological deficits and 58 indicating no neurological deficits. | day 1 | 
| Change from Scandinavian Stroke Scale (SSS) at day 3 | Sum score range from 0 to 58 in the edited version,with 0 indicating severe neurological deficits and 58 indicating no neurological deficits. | day 3 | 
| Change from Scandinavian Stroke Scale (SSS) at day 28 | Sum score range from 0 to 58 in the edited version,with 0 indicating severe neurological deficits and 58 indicating no neurological deficits. | day 28 | 
| Change from Scandinavian Stroke Scale (SSS) at day 72 | Sum score range from 0 to 58 in the edited version,with 0 indicating severe neurological deficits and 58 indicating no neurological deficits. | day 72 | 
| Change from Scandinavian Stroke Scale (SSS) at study end | Sum score range from 0 to 58 in the edited version,with 0 indicating severe neurological deficits and 58 indicating no neurological deficits. | up to 6 month | 
| Early Rehabilitation Barthel Index (ERBI) | Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living. | day 1 | 
| Change from Early Rehabilitation Barthel Index (ERBI) at day 3 | Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living. | day 3 | 
| Change from Early Rehabilitation Barthel Index (ERBI) at day 28 | Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living. | day 28 | 
| Change from Early Rehabilitation Barthel Index (ERBI) at day 72 | Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living. | day 72 | 
| Change from Early Rehabilitation Barthel Index (ERBI) at study end | Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living. | up to 6 month | 
| International Classification of Functioning Disability and Health (ICF) Assessment | A core set consisting of 20 ICF items is used. The severity of each item is scored with zero (no impairment) to four (complete impairment). | day 1 | 
| Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 28 | A core set consisting of 20 ICF items is used. The severity of each item is scored with zero (no impairment) to four (complete impairment). | day 28 | 
| Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 72 | A core set consisting of 20 ICF items is used. The severity of each item is scored with zero (no impairment) to four (complete impairment). | day 72 | 
| Change from International Classification of Functioning Disability and Health (ICF) Assessment at study end | A core set consisting of 20 ICF items is used. The severity of each item is scored with zero (no impairment) to four (complete impairment). | up to 6 month | 
| Early Functional Abilities (EFA) | Sum score range from 20 to 100 points,with 100 indicating no impairement. | day 1 | 
| Change from Early Functional Abilities (EFA) at day 28 | Sum score range from 20 to 100 points,with 100 indicating no impairement. | day 28 | 
| Change from Early Functional Abilities (EFA) at day 72 | Sum score range from 20 to 100 points,with 100 indicating no impairement. | day 72 | 
| Change from Early Functional Abilities (EFA) at study end | Sum score range from 20 to 100 points,with 100 indicating no impairement. | up to 6 month | 
| Adverse events and complications | All adverse events and complications will be documened. | up to 6 month |