Magnesium and Cognition After Stroke

Stroke Clinical Trial

Official title:

Relationship Between Magnesium Concentration in Blood and Kognitive Functions After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132517
• Other study ID #: MaSeKo
• Status: Recruiting
• Start date: October 26, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2022
• Source: BDH-Klinik Hessisch Oldendorf
• Contact: Simone B Schmidt, Dr.
• Phone: 0049 5152 781 215
• Email: si.schmidt[@]nkho.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition
• Magnesium
• Nervous System Diseases
• Neurologic Disorder
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Germany	Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf	Hessisch Oldendorf	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
BDH-Klinik Hessisch Oldendorf

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Classen und Nowitzki. Serum-Magnesium: Normalwerte und Referenzbereiche. Magnesium-Bulletin 1990; 12(4):127-132.

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-0033-135 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	age, gender, ethnic origin	day 1
Other	Location and size of insult	evaluation by CCT or MRT (if available)	day 1
Other	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
Other	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
Other	Medication	Medication affecting mg-absorption and/or -excretion is documented.	day 1
Primary	Serum mg-concentration	This study defines a reference value ranging from 1,8 to 2,53 mg/dl.	day 1
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Lenght of stay	Lenght of stay will be assesse at discharge.	up to 6 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Early Functional Abilities (EFA)	Sum score range from 20 to 100 points,with 100 indicating no impairement.	day 1
Secondary	Change from Early Functional Abilities (EFA) at day 28	Sum score range from 20 to 100 points,with 100 indicating no impairement.	day 28
Secondary	Change from Early Functional Abilities (EFA) at day 72	Sum score range from 20 to 100 points,with 100 indicating no impairement.	day 72
Secondary	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
Secondary	Adverse events and complications	All adverse events and complications will be documened.	up to 6 month