An observational study in Stroke, Brain Disease and Vascular Diseases, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational
Background:
Stroke is the fifth leading cause of death in the United States. It is also a leading cause of disability. More than 70% of people who survive strokes have mental impairment or dementia. Medical factors, such as the severity of the stroke, affect whether a person will have mental impairment afterward. But social factors, such as education and ethnicity, seem to play a role as well. Researchers want to learn more about how social and lifestyle factors affect a person s chances of maintaining mental functions after a stroke.
Objective:
To better understand how social and lifestyle factors affect the risk of mental impairment after a stroke.
Eligibility:
People aged 18 years and older who had a stroke and a brain scan while they were enrolled in NIH Study 01N0007 (Natural History of Stroke Study).
Design:
Participants will have 1 study visit, by telephone. The call will last about 45 minutes. Participants will talk about their health since their stroke. They will answer questions about themselves. Topics will include:
They will have tests of their memory, attention, and language skills. They will repeat numbers and words forward and backward.
Researchers will look at the data and imaging scans collected during participant s enrollment in NIH Study 01N0007. This data will include:
Study Description:
Clinical health outcomes and the likelihood of post stroke cognitive impairment and dementia (PSCID) can greatly vary following stroke incidence. Thus, developing a better understanding of what characteristics might provide resilience and enrich post-stroke recovery is of utmost importance. The NINDS Natural History of Stroke study (01N0007) was designed with the intention to generate natural history data of participants with or at-risk for acute stroke, transient ischemic attack (TIA), and other disturbances of cerebrovascular circulation. Through use of participants enrolled in the Natural History of Stroke study within the past six years, we aim to characterize social determinants of health (SDOH) and present-day cognitive function in this cohort. Following the collection of these data, we will examine how the core volume of acute supratentorial infarcts relates to post-stroke function as measured by the NIHSS, and how this association is modified based upon SDOH features and independent of treatment.
Objectives:
Endpoints:
The primary purpose of this study is to assess SDOH and cognitive function in participants who have had a stroke in the past six years. To this end, the primary study outcomes will be post-stroke function as defined by NIHSS and present-day cognitive function.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 450 is above the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
All participants that were previously enrolled (and had a MRI) within the past 6 years in the NINDS Stroke Branch Natural History study will be recruited for enrollment in the present study. Estimated to be 450 participants (18 and older). Study will consist of one phone call and during the phone call, population will be assessed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this
study:
-Modified Rankin Scale (mRS) = 6 at any follow-up (usually up to 90 days) in the Natural History of Stroke study (mRS = 6 indicates the participant is dead).
Participants who were enrolled in Natural History Study in past 6 years
Post-stroke function as defined by NIH Stroke Scale (NIHSS)
Will use linear regression models to assess association between core infarct volume and post stroke function (as defined by NIHSS) as modified by SDOH
Time frame: NIHSS and core infarct volume gathered at time of enrollment in Natural History of Stroke study, SDOH gathered at present
Present-day cognitive function
Will use linear regression models to assess association between core infarct volume and present-day cognition as modified by SDOH
Time frame: SDOH and present-day cognitive function gathered over phone (present "visit"), other data (including core infarct volume) gathered at time of Natural History of Stroke enrollment
Plan to share: Yes — De-identifiable Individual participant data will be made available across NIMH Data Archive (NDA), an institutional repository supported by NIMH that makes clinical, imaging, and neurosignal data accessible and sharable across scientific domains. NDA provides infrastructure for sharing research data, tools, methods, and analyses enabling collaborative science and discovery. De-identified subjects data, harmonized to a common standard, are available to qualified researchers. Summary data are available to all. De-identifiable data will be made available as soon as possible or at the time of associated publication. The NDA mission is to accelerate scientific research and discovery through data sharing, data harmonization, and the reporting of research results.
Supporting information: Study protocol, Informed consent form
Time frame: De-identifiable data will be made available as soon as possible or at the time of associated publication, whichever comes first.@@@@@@
Access criteria: Requests for data access will need to adhere to the standard processes per each repository. These repositories allow for querying and access to shared datasets.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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