Magnesium and Cognition After Stroke

Relationship Between Magnesium Concentration in Blood and Kognitive Functions After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Neurologic Disorder; Cognition; Magnesium
• Intervention / Treatment: Diagnostic test: Kölner Neuropsychologische Screening für Schlaganfall-Patienten

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?

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Jens D Rollnik, Prof.; Phone Number: 0049 5152 781 231
• Study Contact Backup: Name: Simone B Schmidt, Dr.; Phone Number: 0049 5152 781 215; Email: si.schmidt@nkho.de

Study Locations

• Germany
  • Lower Saxony
    • Hessisch Oldendorf, Lower Saxony, Germany, 31840
      • Recruiting
      • Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
      • Contact: Simone B Schmidt, Dr.; Phone Number: 0049 5152 781 215; Email: si.schmidt@nkho.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Stroke Patients; Ischemic-/hemorragic stroke patients, who admitted on the stroke unit.

Diagnostic test: 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 strokes and covers all stroke relevant domains.; Other Names: KöpSS

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	age, gender, ethnic origin	day 1
Location and size of insult	evaluation by CCT or MRT (if available)	day 1
Charlson Comorbidity Index (CII)	Charlson Comorbidity Index (CII) ranges from 0 to 42, which a score >5 points indicating a 85% mortality risk of one-year death.	day 1
Secondary diagnoses	All secondary diagnoses (i.e. renal insufficiency, Diabetes mellitus, acidosis, alcohol use) which affects mg-absorption and/or -excretion are documented.	day 1
Medication	Medication affecting mg-absorption and/or -excretion is documented.	day 1

Collaborators and Investigators

• Sponsor: BDH-Klinik Hessisch Oldendorf
• Investigators: Principal Investigator: Simone B Schmidt, Dr., BDH-Clinic Hessisch Oldendorf

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Nervous System Diseases
• Other Study ID Numbers: MaSeKo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No