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Magnesium and Cognition After Stroke

ConditionsStrokeCognitionMagnesiumNeurologic Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBDH-Klinik Hessisch Oldendorf

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ischemic/hemmorhagic stroke

written consent form

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Stroke Patients1 intervention

Trial outcomes

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

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BDH-Klinik Hessisch Oldendorf

Lead sponsor

Source ClinicalTrials.gov
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