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Stroke study aims to unlock mystery of white matter brain changes

NCT ID NCT03366129

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study followed 81 adults who had stroke-like symptoms to see how damage to the blood-brain barrier relates to white matter changes in the brain. Over 6 years, participants had regular MRI scans and thinking tests. The goal was to better understand why some people develop mental decline after a stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could help explain why some stroke patients develop thinking problems, pointing toward ways to prevent or slow that decline.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to any direct medical benefit, and results may not apply to all stroke patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

81 people

The number who actually took part.

Started

Sep 2018

Finished

Dec 2023

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Stroke patients will be eligible for this study if their MRI shows evidence of confluent WMH on FLAIR imaging (Fazekas score 2 or greater), obtain a MoCA score greater than 13, and have no other diagnosis to explain the finding (e.g. multiple sclerosis). The NIH stroke service currently evaluates 600 patients a year with MRI. Approximately 20% have confluent WMH on their FLAIR MRI and would meet the inclusion criteria for this study. Thus, the cohort for this study will be recruited from the population evaluated by the NIH stroke service.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: 1. Age greater than or equal to 18 2. Have been evaluated for stroke-like symptoms or have radiographic evidence of stroke on an MRI scan. 3. Is willing to return to one of the two study sites for serial study visits. 4. Is willing to appoint a Durable Power of Attorney (DPA) for NIH research. 5. 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. EXCLUSION CRITERIA: 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • Suburban Hospital - Johns Hopkins

    Bethesda, Maryland, 20814, United States

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