Stroke study aims to unlock mystery of white matter brain changes
NCT ID NCT03366129
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
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81 people
The number who actually took part.
- Started
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Sep 2018
- Finished
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Dec 2023
- Lead sponsor
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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
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Suburban Hospital - Johns Hopkins
Bethesda, Maryland, 20814, United States
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