Clinical 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).
MRI scan: 1\. MRI scan session, which includes Structural, Quantitative, Functional and Diffusion MRI sequences. (maximum duration: 90 min).
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Patient Inclusion Criteria:
* 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.
Patient Exclusion Criteria:
* The DRCMR´s general exclusion criteria for MRI research.
* 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.
Healthy Controls Exclusion Criteria:
* The DRCMR´s general exclusion criteria for MRI research.
* 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.
Healthy Controls Inclusion Criteria:
* 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.
Primary outcome measure(s)
Microstructural changes in the brain network, and its correlate with functional deficits in patients with minor stroke or TIA. — MRI data collected within 3 weeks after the clinical assessment The study assumes that minor stroke or TIA leads to both axonal Wallerian degeneration and demyelination. These pathological changes in the white matter brain network can be captured with a new microstructural anisotropy MRI measure related to cell density, shapes, and a measure of myelination. Therefore, a new microstructural fractional anisotropy measure is expected to be more sensitive to pathology than traditional estimations using the diffusion tensor models, such as diffusion tensor imaging (DTI). Moreover, the structural MRI measures are expected to correlate with clinical assessment.
Trial sites (2)
Facility
City
Region
Status
Bispebjerg Hospital
Copenhagen
København NV
Recruiting
Danish Research Centre for Magnetic Resonance
Copenhagen
Denmark
Recruiting
More Danish Research Centre for Magnetic Resonance trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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