RecruitingNCT04118790

Microstructure Imaging in Stroke Patients

New Clinical Magnetic Resonance Technologies for Capturing Brain Microstructure Alterations in Patients With Minor Stroke or Transient Ischemic Attack


Sponsor

Danish Research Centre for Magnetic Resonance

Enrollment

90 participants

Start Date

Dec 23, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to establish a methodological framework based on existing advanced neuroimaging technologies as a new clinical neuroimaging tool for assessment of possible affected brain connections in stroke and TIA patients. Thus, providing new insights into microstructural changes that may underline why those patients experience deficits like fatigue.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • Stroke or TIA (ABCD2>4 and/or acute Diffusion-Weighted Image (DWI) lesion).
  • Modified Rankin Scale <=2.
  • As perceived by the investigator, have the ability to comply with all requirements of the study protocol.
  • Have the ability to understand and sign the Informed Consents Form.
  • Multidimensional Fatigue Inventory score >= 12 on general fatigue.
  • Healthy
  • Age- and sex-matched to patient groups.
  • As perceived by the investigator, have the ability to comply with all requirements of the study protocol.
  • Have the ability to understand and sign the Informed Consents Form.

Exclusion Criteria16

  • Pregnancy or lactation; human chorionic gonadotropin (hCG) urine test is offered for women < 55 years.
  • Major medical illness (for instance: anemia, diabetes mellitus, thyroid disorders, cardiovascular disease, electrolyte imbalance, etc.)
  • Treated with ritalin or modafinil.
  • Known uncontrolled severe malignancy.
  • Known drug or alcohol addiction.
  • Tiredness due to pharmaceutical side effects, as identified by the Investigator.
  • Max body weight of 130 kg.
  • Persons who do not wish to be informed about abnormal findings as part of the investigations.
  • Pregnancy or lactation; urin hCG test is offered for women < 55 years.
  • Major medical illness (for instance: anemia, diabetes mellitus, thyroid disorders, cardiovascular disease, electrolyte imbalance, etc.)
  • Anamnestic infection (cystitis, influenza, pneumonia, etc) the last 3 weeks.
  • Known malignancy.
  • Known drug or alcohol addiction.
  • Tiredness due to pharmaceutical side effects.
  • Max body weight of 130 kg.
  • Persons who do not wish to be informed about abnormal findings as part of the investigations.

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Interventions

OTHERClinical Assessment

1. Medical history and details of the vascular incident will be collected from the patient and the medical journal. (Duration: 1hr) 2. Neuropsychological measures collected using test measures and questionaries (duration approx 45-60 min).

PROCEDUREMRI scan

1\. MRI scan session, which includes Structural, Quantitative, Functional and Diffusion MRI sequences. (maximum duration: 90 min).


Locations(2)

Bispebjerg Hospital

Copenhagen, København NV, Denmark

Danish Research Centre for Magnetic Resonance

Copenhagen, Denmark

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NCT04118790


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