NCT04118790Recruiting
Microstructure Imaging in Stroke Patients
New Clinical Magnetic Resonance Technologies for Capturing Brain Microstructure Alterations in Patients With Minor Stroke or Transient Ischemic Attack
Source: ClinicalTrials.gov · Last updated 26 May 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 4 Oct 2019
- Start date
- 23 Dec 2019
- Primary completion date
- 1 Sept 2023
- Lead sponsor
- Danish Research Centre for Magnetic Resonance
- Diseases
- Stroke
- NCT number
- NCT04118790
What you commit to
- Study type: Observational
- Planned participants: 90
- From 23 Dec 2019 to the primary completion date, 1 Sept 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Danish Research Centre for Magnetic Resonance Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.