Microstructure Imaging in Stroke Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDanish Research Centre for Magnetic Resonance
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population is in total 90 participants, from which, 3 groups are divided: 30 minor Stroke patients, 30 TIA patients, and 30 healthy controls. * The 2 groups of patients, minor Stroke and TIA, will be recruited from Department of Neurology, Bispebjerg Hospital. * The healthy age- and sex-matched individuals for the control group will be recruited from the general population.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Clinical Assessment
Other intervention1. 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
Procedure/Surgery1\. MRI scan session, which includes Structural, Quantitative, Functional and Diffusion MRI sequences. (maximum duration: 90 min).
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Minor Stroke patients2 interventions
Group B: TIA patients2 interventions
Group C: Healthy Controls1 intervention
Trial outcomes
Primary outcomes
1
Microstructural changes in the brain network, and its correlate with functional deficits in patients with minor stroke or TIA.
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.
Time frame
MRI data collected within 3 weeks after the clinical assessmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Danish Research Centre for Magnetic Resonance
Lead sponsor
Bispebjerg Hospital
Collaborator
Source ClinicalTrials.gov