Magnesium and Cognition After Stroke

NCT05132517 | Recruiting

• 1 other identifier: MaSeKo
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Cognition; Magnesium; Neurologic Disorder

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (28)

• Mini Mental State Test (MMST)

  day 3

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

  day 28

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

  day 72

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

  up to 6 month

• Modified Rankin Scale (MRS)

  day 1

Other Outcomes (5)

• Demographics

  day 1

• Location and size of insult

  day 1

• Charlson Comorbidity Index (CII)

  day 1

Study Arms (1)

Stroke Patients

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

Diagnostic Test: Kölner Neuropsychologische Screening für Schlaganfall-Patienten

Interventions

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.

Also known as: KöpSS

Stroke Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ischemic/hemmorhagic stroke
• written consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead

Study Sites (1)

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

RECRUITING

Related Publications (3)

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

  BACKGROUND

• 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.

  PMID: 30464479 RESULT

• 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.

  PMID: 23986457 RESULT

MeSH Terms

Conditions

Stroke; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Simone B Schmidt, Dr.

  BDH-Clinic Hessisch Oldendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone B Schmidt, Dr.

CONTACT

0049 5152 781 215; si.schmidt@nkho.de

Jens D Rollnik, Prof.

CONTACT

0049 5152 781 231

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 24, 2021
• Study Start: October 26, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

DE (1)