Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke

Completed

Conditions studied: Cerebrovascular Disorder, Stroke, Aging

In brief

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.

Key facts

Study ID

NCT03366129

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

81

Starts

2018-09-06

Expected to finish

2023-12-18

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from this study:
• Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed)
• Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected
• If unable to lie comfortably on their back for up to 1 hour.
• Contraindication to gadolinium (pregnant or nursing, previous allergic reaction, renal insufficiency)
• Known diagnosis that is thought to be the cause of their WMH (e.g. multiple sclerosis) other than chronic cerebrovascular disease, cerebral autosomal dominant arteriopathy with subcortical infarcts (CADASIL), or migraine.
• Clinically significant medical or neurological disorders that might expose the patient to undue risk of harm, confound study outcomes or prevent the participant from completing the study; examples of such conditions include but are not limited to respiratory compromise, cardiovascular instability or cerebral edema.
• History of an ongoing seizure disorder, structural brain abnormality or nonvascular brain injury.
• Unlikely to be released from the hospital following the qualifying event or has severe disability preventing ambulation or verbal communication.
• Known malignant disease or other chronic illness with poor 5-year prognosis other than dementia.
• Attaining a six-item screener score less than 4, during screening.

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Suburban Hospital - Johns Hopkins — Bethesda, Maryland, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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