Magnesium and Cognition After Stroke

Официальное название

Relationship Between Magnesium Concentration in Blood and Kognitive Functions After Stroke

Обзор

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.

Подробное описание

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:

1. What is the incidence of cognitive impairments in stroke patients?

1. Are there differences between ischemic and hemorrhagic stroke patients? 2. Are there age and/or gender differences? 2. 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? 3. Is there a correlation between the mg-concentration and the stroke severity? 4. Is there a correlation between the scores of the different cognitive tests (MMST and KöpSS)? 5. Is there an association between the stroke severity, the cognitive impairments (KöpSS) and the neuronal attention network?

Вмешательства

• Диагностический тест Kölner Neuropsychologische Screening für Schlaganfall-Patienten
  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 st

Первичные конечные точки

• Serum mg-concentration [Срок оценки: day 1]
• Change from Serum mg-concentration from admission at day 28 [Срок оценки: day 28]
• Change from Serum mg-concentration from admission at day 72 [Срок оценки: day 72]
• Change from Serum mg-concentration from admission at study end [Срок оценки: up to 6 month]
• Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) [Срок оценки: day 3]
• Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 28 [Срок оценки: day 28]
• Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 72 [Срок оценки: day 72]
• Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at study end [Срок оценки: up to 6 month]
• National Institutes of Health Stroke Scale [Срок оценки: day 1]
• Change from National Institutes of Health Stroke Scale at day 3 [Срок оценки: day 3]

Вторичные конечные точки (12)

• Mini Mental State Test (MMST) [Срок оценки: day 3]
• Change from Mini Mental State Test (MMST) at day 28 [Срок оценки: day 28]
• Change from Mini Mental State Test (MMST) at day 72 [Срок оценки: day 72]
• Change from Mini Mental State Test (MMST) at study end [Срок оценки: up to 6 month]
• Modified Rankin Scale (MRS) [Срок оценки: day 1]
• Change from Modified Rankin Scale (MRS) at day 3 [Срок оценки: day 3]
• Change from Modified Rankin Scale (MRS) at day 28 [Срок оценки: day 28]
• Change from Modified Rankin Scale (MRS) at day 72 [Срок оценки: day 72]
• Change from Modified Rankin Scale (MRS) at study end [Срок оценки: up to 6 month]
• Scandinavian Stroke Scale (SSS) [Срок оценки: day 1]
• Change from Scandinavian Stroke Scale (SSS) at day 3 [Срок оценки: day 3]
• Change from Scandinavian Stroke Scale (SSS) at day 28 [Срок оценки: day 28]

Критерии участия

Критерии включения

• ischemic/hemmorhagic stroke
• written consent form

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf — Hessisch Oldendorf

Публикации

• Classen und Nowitzki. Serum-Magnesium: Normalwerte und Referenzbereiche. Magnesium-Bulletin 1990; 12(4):127-132.
• Tu X, Qiu H, Lin S, He W, Huang G, Zhang X, Wu Y, He J. Low levels of serum magnesium are associated with poststroke cognitive impairment in ischemic stroke patients. Neuropsychiatr Dis Treat. 2018 Nov 2;14:2947-2954. doi: 10.2147/NDT.S181948. eCollection 2018. PMID 30464479
• Kaesberg S, Fink GR, Kalbe E. [Neuropsychological assessment early after stroke--an overview of diagnostic instruments available in German and introduction of a new screening tool]. Fortschr Neurol Psychiatr. 2013 Sep;81(9):482-92. doi: 10.1055/s-0033-1350452. Epub 2013 Aug 28. German. PMID 23986457

Идентификаторы

NCT: NCT05132517 · MaSeKo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗