Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke (NCT03366129) | Clinical Trial Compass
CompletedNot Applicable
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
United States81 participantsStarted 2018-09-06
Plain-language summary
Background:
A stroke occurs when not enough blood reaches the brain. Sometimes stroke causes changes in certain brain matter. This is called white matter hyperintensity (WMH) and can lead to mental decline. But not all WMH is caused by stroke. Not all people with WMH experience mental decline. Researchers want to learn more about WMH. They want to see if it is related to disruptions in the blood-brain barrier.
Objective:
To better understand the how blood-brain barrier disruption is related to white matter hyperintensities.
Eligibility:
Adults at least 18 years old who have been admitted to a study site with stroke-like symptoms
Design:
Participants will be screened with an MRI scan and cognitive tests.
Participants will have 11 visits over 6 years. Each visit will be 3-4 hours.
At each visit, participants will:
Update their medical history
Have a thin plastic tube (catheter) inserted into an arm vein by needle
Have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will be in the scanner about 60 minutes, lying still for up to 20 minutes at a time. They will get earmuffs for loud sounds.
Have a dye injected through the catheter during the MRI
Have tests of movement, language, and cognition
Some participants will have an extra visit for an MRI in a stronger scanner (7T MRI).
Participation for some participants will be authorized by their legal representative.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age greater than or equal to 18
. Have been evaluated for stroke-like symptoms or have radiographic evidence of stroke on an MRI scan.
. Is willing to return to one of the two study sites for serial study visits.
. Is willing to appoint a Durable Power of Attorney (DPA) for NIH research.
. Is willing to provide written informed consent prior to participation OR a qualifying LAR will provide consent and the subject is able to provide assent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at the link between blood-brain barrier disruption and white matter changes after stroke — can you explain what white matter hyperintensities are and whether my own brain scans show any signs of them?
2Since this study is completed, have the results been published yet, and if so, what did they find about whether blood-brain barrier leakage predicts how white matter damage progresses after stroke?
3The trial focused on people who had already had a stroke — based on my situation, do you think the findings from this research are relevant to my care, and should they change how closely we monitor my brain health going forward?
4If blood-brain barrier disruption turns out to be an early warning sign of worsening white matter disease, are there any treatments or lifestyle changes I should consider now to try to slow that progression?
5Are there any follow-up studies or active trials building on this research that might be worth discussing as an option for me, given that this particular trial is already completed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome is the relationship between BBB disruption and WMH progression. It is postulated that BBB disruption in the NAWM will be associated with progression of the WMH.
Timeframe: Assessed at each research time point
Trial details
NCT IDNCT03366129
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)