Clinical trial NCT05132517: Magnesium and Cognition After Stroke
Official title: Relationship Between Magnesium Concentration in Blood and Kognitive Functions After Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Cognition
Magnesium
Neurologic Disorder
Lead sponsor: BDH-Klinik Hessisch Oldendorf
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The sample is comprised of 80 stroke patients (ischemic/hemmorgic) of both genders and age ≥ 18 years. A written consent form is signed before inclusion.

Brief summary: 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: 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?

Eligibility criteria: 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

Primary outcomes:
measure: Serum mg-concentration
timeFrame: day 1
measure: Change from Serum mg-concentration from admission at day 28
timeFrame: day 28
measure: Change from Serum mg-concentration from admission at day 72
timeFrame: day 72
measure: Change from Serum mg-concentration from admission at study end
timeFrame: up to 6 month
measure: Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS)
timeFrame: day 3
measure: Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 28
timeFrame: day 28
measure: Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 72
timeFrame: day 72
measure: Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at study end
timeFrame: up to 6 month
measure: National Institutes of Health Stroke Scale
timeFrame: day 1
measure: Change from National Institutes of Health Stroke Scale at day 3
timeFrame: day 3
measure: Change from National Institutes of Health Stroke Scale at day 28
timeFrame: day 28
measure: Change from National Institutes of Health Stroke Scale at day 72
timeFrame: day 72
measure: Change from National Institutes of Health Stroke Scale at study end
timeFrame: up to 6 month
measure: Lenght of stay
timeFrame: up to 6 month
Secondary outcomes:
measure: Mini Mental State Test (MMST)
timeFrame: day 3
measure: Change from Mini Mental State Test (MMST) at day 28
timeFrame: day 28
measure: Change from Mini Mental State Test (MMST) at day 72
timeFrame: day 72
measure: Change from Mini Mental State Test (MMST) at study end
timeFrame: up to 6 month
measure: Modified Rankin Scale (MRS)
timeFrame: day 1
measure: Change from Modified Rankin Scale (MRS) at day 3
timeFrame: day 3
measure: Change from Modified Rankin Scale (MRS) at day 28
timeFrame: day 28
measure: Change from Modified Rankin Scale (MRS) at day 72
timeFrame: day 72
measure: Change from Modified Rankin Scale (MRS) at study end
timeFrame: up to 6 month
measure: Scandinavian Stroke Scale (SSS)
timeFrame: day 1
measure: Change from Scandinavian Stroke Scale (SSS) at day 3
timeFrame: day 3
measure: Change from Scandinavian Stroke Scale (SSS) at day 28
timeFrame: day 28
measure: Change from Scandinavian Stroke Scale (SSS) at day 72
timeFrame: day 72
measure: Change from Scandinavian Stroke Scale (SSS) at study end
timeFrame: up to 6 month
measure: Early Rehabilitation Barthel Index (ERBI)
timeFrame: day 1
measure: Change from Early Rehabilitation Barthel Index (ERBI) at day 3
timeFrame: day 3
measure: Change from Early Rehabilitation Barthel Index (ERBI) at day 28
timeFrame: day 28
measure: Change from Early Rehabilitation Barthel Index (ERBI) at day 72
timeFrame: day 72
measure: Change from Early Rehabilitation Barthel Index (ERBI) at study end
timeFrame: up to 6 month
measure: International Classification of Functioning Disability and Health (ICF) Assessment
timeFrame: day 1
measure: Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 28
timeFrame: day 28
measure: Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 72
timeFrame: day 72
measure: Change from International Classification of Functioning Disability and Health (ICF) Assessment at study end
timeFrame: up to 6 month
measure: Early Functional Abilities (EFA)
timeFrame: day 1
measure: Change from Early Functional Abilities (EFA) at day 28
timeFrame: day 28
measure: Change from Early Functional Abilities (EFA) at day 72
timeFrame: day 72
measure: Change from Early Functional Abilities (EFA) at study end
timeFrame: up to 6 month
measure: Adverse events and complications
timeFrame: up to 6 month
Other outcomes:
measure: Demographics
timeFrame: day 1
measure: Location and size of insult
timeFrame: day 1
measure: Charlson Comorbidity Index (CII)
timeFrame: day 1
measure: Secondary diagnoses
timeFrame: day 1
measure: Medication
timeFrame: day 1
Locations:
city: Hessisch Oldendorf
country: Germany
facility: Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
state: Lower Saxony
Study officials:
affiliation: BDH-Clinic Hessisch Oldendorf
name: Simone B Schmidt, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Classen und Nowitzki. Serum-Magnesium: Normalwerte und Referenzbereiche. Magnesium-Bulletin 1990; 12(4):127-132.
citation: 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.
citation: 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.