ClinicalTrials.gg
Sign In
RecruitingNCT05132517Updated Apr 20, 2026

Magnesium and Cognition After Stroke

An observational study in Stroke, Cognition and Magnesium, sponsored by BDH-Klinik Hessisch Oldendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by BDH-Klinik Hessisch Oldendorf · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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?
02

Conditions studied

  • Stroke
  • Cognition
  • Magnesium
  • Neurologic Disorder
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 80 is below the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

BDH-Klinik Hessisch Oldendorf is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ischemic/hemmorhagic stroke
  • written consent form

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Stroke Patients

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

    Diagnostic Test: Kölner Neuropsychologische Screening für Schlaganfall-Patienten

Interventions

  • Diagnostic testKölner 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.

    Also known as: KöpSS

06

What researchers measure

Primary outcomes

  1. Serum mg-concentration

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

    Time frame: day 1

  2. 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.

    Time frame: day 28

  3. 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.

    Time frame: day 72

  4. 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.

    Time frame: up to 6 month

  5. 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.

    Time frame: day 3

  6. 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.

    Time frame: day 28

  7. 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.

    Time frame: day 72

  8. 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.

    Time frame: up to 6 month

  9. 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

    Time frame: day 1

  10. 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

    Time frame: day 3

  11. 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

    Time frame: day 28

  12. 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

    Time frame: day 72

  13. 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

    Time frame: up to 6 month

  14. Lenght of stay

    Lenght of stay will be assesse at discharge.

    Time frame: up to 6 month

Secondary outcomes

  1. 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

    Time frame: day 3

  2. 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

    Time frame: day 28

  3. 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

    Time frame: day 72

  4. 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

    Time frame: up to 6 month

  5. 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.

    Time frame: day 1

  6. 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.

    Time frame: day 3

  7. 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.

    Time frame: day 28

  8. 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.

    Time frame: day 72

  9. 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.

    Time frame: up to 6 month

  10. 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.

    Time frame: day 1

  11. 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.

    Time frame: day 3

  12. 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.

    Time frame: day 28

  13. 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.

    Time frame: day 72

  14. 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.

    Time frame: up to 6 month

  15. Early Rehabilitation Barthel Index (ERBI)

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

    Time frame: day 1

  16. 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.

    Time frame: day 3

  17. 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.

    Time frame: day 28

  18. 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.

    Time frame: day 72

  19. 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.

    Time frame: up to 6 month

  20. 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").

    Time frame: day 1

  21. 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").

    Time frame: day 28

  22. 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").

    Time frame: day 72

  23. 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").

    Time frame: up to 6 month

  24. Early Functional Abilities (EFA)

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

    Time frame: day 1

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

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

    Time frame: day 28

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

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

    Time frame: day 72

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

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

    Time frame: up to 6 month

  28. Adverse events and complications

    All adverse events and complications will be documened.

    Time frame: up to 6 month

Other outcomes

  1. Demographics

    age, gender, ethnic origin

    Time frame: day 1

  2. Location and size of insult

    evaluation by CCT or MRT (if available)

    Time frame: day 1

  3. 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.

    Time frame: day 1

  4. Secondary diagnoses

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

    Time frame: day 1

  5. Medication

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

    Time frame: day 1

07

Study locations

1 of 1 sites recruiting
  • Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
    Hessisch Oldendorf, Lower Saxony 31840, Germany
    Recruiting
08

References and documents

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. PubMed 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. PubMed 23986457 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Dec 2026, 50 months after the start.

Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 50 months is above that.

Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2021
First posted
Nov 24, 2021
StartActual
Oct 26, 2022
Primary completionEst.
Dec 31, 2026
CompletionEst.
Sep 30, 2027
Last update
Apr 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05132517
Lead sponsor
BDH-Klinik Hessisch Oldendorf
Responsible party
Sponsor
First posted
Nov 24, 2021
Start date
Oct 26, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Apr 20, 2026

Study contacts

Simone B Schmidt, Dr.
Contact
si.schmidt@nkho.de
0049 5152 781 215
Jens D Rollnik, Prof.
Contact
0049 5152 781 231
Simone B Schmidt, Dr.
principal investigator · BDH-Clinic Hessisch Oldendorf

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stroke →

Other studies from this sponsor

BDH-Klinik Hessisch Oldendorf

Start the discussion