Using advanced MRI to study brain changes in stroke patients
New Clinical Magnetic Resonance Technologies for Capturing Brain Microstructure Alterations in Patients With Minor Stroke or Transient Ischemic Attack
This study is testing a new MRI technique to see how stroke and TIA affect brain connections and if this helps explain the fatigue that many patients feel afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danish Research Centre for Magnetic Resonance Academic / other |
| Locations | 2 sites (Copenhagen, København NV and 1 other locations) |
| Trial ID | NCT04118790 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a new clinical neuroimaging tool that utilizes advanced MRI technologies to assess microstructural changes in the brains of stroke and transient ischemic attack (TIA) patients. By focusing on the connections in the brain that may be affected by these conditions, the study seeks to provide insights into the underlying causes of fatigue experienced by these patients. Participants will undergo clinical assessments and MRI scans to evaluate their brain microstructures and the potential impact of ischemic injuries. The findings could lead to improved understanding and management of post-stroke fatigue.
Who should consider this trial
Good fit: Ideal candidates include individuals who have experienced a stroke or TIA and exhibit moderate fatigue.
Not a fit: Patients with major medical illnesses or those who do not wish to be informed about abnormal findings may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of fatigue in stroke patients, leading to better treatment strategies.
How similar studies have performed: While there have been studies utilizing advanced MRI techniques, this specific approach focusing on microstructural changes in stroke patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Copenhagen, København NV and 1 other locations
- Bispebjerg Hospital — Copenhagen, København NV, Denmark (Recruiting)
- Danish Research Centre for Magnetic Resonance — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Tim B. Dyrby, Professor — Danish Research Centre for Magnetic Resonance
- Study coordinator: Maria del Carmen Moreno Genis, MSc
- Email: carmenmg@drcmr.dk
- Phone: 38626446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.