StrokeNCT05132517
Magnesium and Cognition After Stroke
An observational study of Stroke and Cognition, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Kölner Neuropsychologische Screening für Schlaganfall-Patienten
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 26 Oct 2022to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ischemic/hemmorhagic stroke
- written consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jens D Rollnik, Prof. contact
Germany1 site, 1 recruiting
- Recruiting
Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
Hessisch Oldendorf, Lower Saxony, 31840
Simone B Schmidt, Dr., 0049 5152 781 215, si.schmidt@nkho.de
About this study
Official title: 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.
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:
- 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?
- Conditions
- Stroke, Cognition, Magnesium, Neurologic Disorder
- Being tested
- Kölner Neuropsychologische Screening für Schlaganfall-Patienten
- Medical subject headings
- Stroke, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kölner Neuropsychologische Screening für Schlaganfall-PatientenDiagnostic test
Also called KöpSS
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Patients | Ischemic-/hemorragic stroke patients, who admitted on the stroke unit. Receives: Diagnostic Test: Kölner Neuropsychologische Screening für Schlaganfall-Patienten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum mg-concentration
This study defines a reference value ranging from 1,8 to 2,53 mg/dl.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 6 month
Lenght of stay
Lenght of stay will be assesse at discharge.
Measured: up to 6 month
Secondary outcomes (28)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: up to 6 month
Early Functional Abilities (EFA)
Sum score range from 20 to 100 points,with 100 indicating no impairement.
Measured: day 1
Change from Early Functional Abilities (EFA) at day 28
Sum score range from 20 to 100 points,with 100 indicating no impairement.
Measured: day 28
Change from Early Functional Abilities (EFA) at day 72
Sum score range from 20 to 100 points,with 100 indicating no impairement.
Measured: day 72
Change from Early Functional Abilities (EFA) at study end
Sum score range from 20 to 100 points,with 100 indicating no impairement.
Measured: up to 6 month
Adverse events and complications
All adverse events and complications will be documened.
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start26 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone B Schmidt, Dr., Principal investigator, BDH-Clinic Hessisch Oldendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132517
- Sponsor's protocol ID
- MaSeKo
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2021
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 30464479Kaesberg 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Magnesium Concentration in Blood and Kognitive Functions After Stroke
- ClinicalTrials.gov ID
- NCT05132517
- Acronym / sponsor ID
- MaSeKo
- Conditions
- Stroke, Cognition, Magnesium, Neurologic Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- BDH-Klinik Hessisch OldendorfUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Patients | – | Diagnostic Test: Kölner Neuropsychologische Screening für Schlaganfall-PatientenIschemic-/hemorragic stroke patients, who admitted on the stroke unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ischemic/hemmorhagic stroke
- written consent form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kölner Neuropsychologische Screening für Schlaganfall-PatientenAlso: KöpSSThe 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. | Diagnostic test | Stroke Patients |
Primary outcome
Serum mg-concentration
Time frame: day 1
This study defines a reference value ranging from 1,8 to 2,53 mg/dl.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
Lenght of stay
Time frame: up to 6 month
Lenght of stay will be assesse at discharge.
28 secondary outcomes
Mini Mental State Test (MMST)
Time frame: day 3
Change from Mini Mental State Test (MMST) at day 28
Time frame: day 28
Change from Mini Mental State Test (MMST) at day 72
Time frame: day 72
Change from Mini Mental State Test (MMST) at study end
Time frame: up to 6 month
Modified Rankin Scale (MRS)
Time frame: day 1
Change from Modified Rankin Scale (MRS) at day 3
Time frame: day 3
Change from Modified Rankin Scale (MRS) at day 28
Time frame: day 28
Change from Modified Rankin Scale (MRS) at day 72
Time frame: day 72
Change from Modified Rankin Scale (MRS) at study end
Time frame: up to 6 month
Scandinavian Stroke Scale (SSS)
Time frame: day 1
Change from Scandinavian Stroke Scale (SSS) at day 3
Time frame: day 3
Change from Scandinavian Stroke Scale (SSS) at day 28
Time frame: day 28
Change from Scandinavian Stroke Scale (SSS) at day 72
Time frame: day 72
Change from Scandinavian Stroke Scale (SSS) at study end
Time frame: up to 6 month
Early Rehabilitation Barthel Index (ERBI)
Time frame: day 1
Change from Early Rehabilitation Barthel Index (ERBI) at day 3
Time frame: day 3
Change from Early Rehabilitation Barthel Index (ERBI) at day 28
Time frame: day 28
Change from Early Rehabilitation Barthel Index (ERBI) at day 72
Time frame: day 72
Change from Early Rehabilitation Barthel Index (ERBI) at study end
Time frame: up to 6 month
International Classification of Functioning Disability and Health (ICF) Assessment
Time frame: day 1
Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 28
Time frame: day 28
Change from International Classification of Functioning Disability and Health (ICF) Assessment at day 72
Time frame: day 72
Change from International Classification of Functioning Disability and Health (ICF) Assessment at study end
Time frame: up to 6 month
Early Functional Abilities (EFA)
Time frame: day 1
Change from Early Functional Abilities (EFA) at day 28
Time frame: day 28
Change from Early Functional Abilities (EFA) at day 72
Time frame: day 72
Change from Early Functional Abilities (EFA) at study end
Time frame: up to 6 month
Adverse events and complications
Time frame: up to 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- BackgroundClassen und Nowitzki. Serum-Magnesium: Normalwerte und Referenzbereiche. Magnesium-Bulletin 1990; 12(4):127-132.
- Results publication: PubMed 30464479Tu 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.
- Results publication: PubMed 23986457Kaesberg 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens D Rollnik, Prof. contact
Simone B Schmidt, Dr. principal investigator
BDH-Clinic Hessisch Oldendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cognition, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone B Schmidt, Dr. (0049 5152 781 215, si.schmidt@nkho.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum mg-concentration (time frame: day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05132517, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.