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NCT Number: NCT05132517

Magnesium and Cognition 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Magnesium Nervous System Diseases Neurologic Disorder Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

Location status: Recruiting

Location contact

Simone B Schmidt, Dr.

CONTACT

[email protected]

0049 5152 781 215

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kölner Neuropsychologische Screening für Schlaganfall-Patienten

Diagnostic Test

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

Primary outcomes

  1. Serum mg-concentration

    Time frame: day 1

    This study defines a reference value ranging from 1,8 to 2,53 mg/dl.

  2. Change from Serum mg-concentration from admission at day 28

    Time frame: day 28

    This study defines a reference value ranging from 1,8 to 2,53 mg/dl.

  3. Change from Serum mg-concentration from admission at day 72

    Time frame: day 72

    This study defines a reference value ranging from 1,8 to 2,53 mg/dl.

  4. Change from Serum mg-concentration from admission at study end

    Time frame: up to 6 month

    This study defines a reference value ranging from 1,8 to 2,53 mg/dl.

  5. Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS)

    Time frame: day 3

    The score ranges from 0 to 108 points. If all subtest can be performed, a score <98 points identify an impaired cognition.

  6. Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 28

    Time frame: day 28

    The score ranges from 0 to 108 points. If all subtest can be performed, a score <98 points identify an impaired cognition.

  7. Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at day 72

    Time frame: day 72

    The score ranges from 0 to 108 points. If all subtest can be performed, a score <98 points identify an impaired cognition.

  8. Change from Kölner Neuropsychologische Screening für Schlaganfall-Patienten (KöpSS) at study end

    Time frame: 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.

  9. National Institutes of Health Stroke Scale

    Time frame: day 1

    0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke;

    ≥25 points: very severe stroke

  10. Change from National Institutes of Health Stroke Scale at day 3

    Time frame: day 3

    0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke;

    ≥25 points: very severe stroke

  11. Change from National Institutes of Health Stroke Scale at day 28

    Time frame: day 28

    0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke;

    ≥25 points: very severe stroke

  12. Change from National Institutes of Health Stroke Scale at day 72

    Time frame: day 72

    0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke;

    ≥25 points: very severe stroke

  13. Change from National Institutes of Health Stroke Scale at study end

    Time frame: up to 6 month

    0-5 points: mild stroke; 6-14 points: moderate stroke; 15- 24 points: severe stroke;

    ≥25 points: very severe stroke

  14. Lenght of stay

    Time frame: up to 6 month

    Lenght of stay will be assesse at discharge.

Secondary outcomes

  1. Mini Mental State Test (MMST)

    Time frame: day 3

    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

  2. Change from Mini Mental State Test (MMST) at day 28

    Time frame: 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

  3. Change from Mini Mental State Test (MMST) at day 72

    Time frame: 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

  4. Change from Mini Mental State Test (MMST) at study end

    Time frame: up to 6 month

    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

  5. Modified Rankin Scale (MRS)

    Time frame: day 1

    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.

  6. Change from Modified Rankin Scale (MRS) at day 3

    Time frame: 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.

  7. Change from Modified Rankin Scale (MRS) at day 28

    Time frame: 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.

  8. Change from Modified Rankin Scale (MRS) at day 72

    Time frame: 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.

  9. Change from Modified Rankin Scale (MRS) at study end

    Time frame: up to 6 month

    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.

  10. Scandinavian Stroke Scale (SSS)

    Time frame: day 1

    Sum score range from 0 to 58 in the edited version,with 0 indicating severe neurological deficits and 58 indicating no neurological deficits.

  11. Change from Scandinavian Stroke Scale (SSS) at day 3

    Time frame: 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.

  12. Change from Scandinavian Stroke Scale (SSS) at day 28

    Time frame: 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.

  13. Change from Scandinavian Stroke Scale (SSS) at day 72

    Time frame: 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.

  14. Change from Scandinavian Stroke Scale (SSS) at study end

    Time frame: up to 6 month

    Sum score range from 0 to 58 in the edited version,with 0 indicating severe neurological deficits and 58 indicating no neurological deficits.

  15. Early Rehabilitation Barthel Index (ERBI)

    Time frame: day 1

    Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living.

  16. Change from Early Rehabilitation Barthel Index (ERBI) at day 3

    Time frame: day 3

    Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living.

  17. Change from Early Rehabilitation Barthel Index (ERBI) at day 28

    Time frame: day 28

    Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living.

  18. Change from Early Rehabilitation Barthel Index (ERBI) at day 72

    Time frame: day 72

    Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living.

  19. Change from Early Rehabilitation Barthel Index (ERBI) at study end

    Time frame: up to 6 month

    Sum score range from -325 to 100 points,with 100 indicating independence in the activity of daily living.

  20. International Classification of Functioning Disability and Health (ICF) Assessment

    Time frame: day 1

    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").

  21. Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 28

    Time frame: 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").

  22. Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 72

    Time frame: 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").

  23. Change from International Classification of Functioning Disability and Health (ICF) Assessment at study end

    Time frame: up to 6 month

    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").

  24. Early Functional Abilities (EFA)

    Time frame: day 1

    Sum score range from 20 to 100 points,with 100 indicating no impairement.

  25. Change from Early Functional Abilities (EFA) at day 28

    Time frame: day 28

    Sum score range from 20 to 100 points,with 100 indicating no impairement.

  26. Change from Early Functional Abilities (EFA) at day 72

    Time frame: day 72

    Sum score range from 20 to 100 points,with 100 indicating no impairement.

  27. Change from Early Functional Abilities (EFA) at study end

    Time frame: up to 6 month

    Sum score range from 20 to 100 points,with 100 indicating no impairement.

  28. Adverse events and complications

    Time frame: up to 6 month

    All adverse events and complications will be documened.

Other outcomes

  1. Demographics

    Time frame: day 1

    age, gender, ethnic origin

  2. Location and size of insult

    Time frame: day 1

    evaluation by CCT or MRT (if available)

  3. Charlson Comorbidity Index (CII)

    Time frame: day 1

    Charlson Comorbidity Index (CII) ranges from 0 to 42, which a score >5 points indicating a 85% mortality risk of one-year death.

  4. Secondary diagnoses

    Time frame: day 1

    All secondary diagnoses (i.e. renal insufficiency, Diabetes mellitus, acidosis, alcohol use) which affects mg-absorption and/or -excretion are documented.

  5. Medication

    Time frame: day 1

    Medication affecting mg-absorption and/or -excretion is documented.

Study contacts

Contact information is provided by the study sponsor or research team.

Jens D Rollnik, Prof.

CONTACT

0049 5152 781 231

Simone B Schmidt, Dr.

CONTACT

[email protected]

0049 5152 781 215

Sponsors and collaborators

Lead sponsor

BDH-Klinik Hessisch Oldendorf

Other

Registry information

Official study title

Relationship Between Magnesium Concentration in Blood and Kognitive Functions After Stroke

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Nov 24, 2021
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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