StrokeNCT06615973
Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke
An observational study of Stroke and Brain Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Brain Disease, Vascular Diseases
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Adults aged 18 or older.
- Previous participant in the Natural History of Stroke with an interpretable baseline MRI scan, NIHSS measured at baseline or discharge, and admission diagnosis of ischemic stroke.
- Fluent in English or Spanish
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Understanding Stroke Outcomes: Stroke Resilience, Infarct Burden, and Long-Term Cognition
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.
Read more
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:
- Their race
- Education
- Ethnicity
- Employment
- Marital status
- Residence address
- Recent health history
- Medical insurance
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:
- The hospital that first saw the participant at the time of their stroke.
- The type of imaging that was first used then.
- The primary diagnosis at admission.
- Other medical details.
Read the detailed description
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:
- To characterize SDOH and assess if such characteristics modify the relationship between MRI core infarct volume and post-stroke function (i.e., NIHSS) at baseline and/or discharge. Resilience will thus be assessed by evaluating how specified SDOH modify the correlation between MRI core infarct volume and NIHSS.
- To assess present cognitive function and assess if SDOH modify the relationship between MRI core infarct volume and present-day cognition. Resilience will thus be assessed by evaluating how SDOH modify the correlation between infarct volume and present-day cognition.
- To assess if SDOH modify the relationship between poststroke function (i.e. NIHSS) at baseline and/or discharge with present-day cognition. Resilience will thus be assessed by evaluating how SDOH modify the correlation between NIHSS and present-day cognition.
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.
- Primary Endpoint: Association between MRI core infarct volume and post-stroke function (i.e. NIHSS) as modified by SDOH.
- Secondary Endpoints: Association between MRI core infarct volume and present-day cognitive function as modified by SDOH.
- Conditions
- Stroke, Brain Disease, Vascular Diseases, Cerebrovascular Disorder
- Keywords
- Stroke, Social Determinants of Health, Cognition, cerebrovascular health, Magnetic Resonance Imaging (MRI), vascular health
- Medical subject headings
- Stroke, Brain Diseases, Vascular Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Participants who were enrolled in Natural History Study in past 6 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: NIHSS and core infarct volume gathered at time of enrollment in Natural History of Stroke study, SDOH gathered at present
Secondary outcomes (1)
Present-day cognitive function
Will use linear regression models to assess association between core infarct volume and present-day cognition as modified by SDOH
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start14 Sep 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rebecca F Gottesman, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615973
- Sponsor's protocol ID
- 10001861
- Other IDs
- 001861-N
- Status last verified
- 26 Sep 2026
- First submitted
- 25 Sep 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
PubMed 28122885Chalela JA, Kidwell CS, Nentwich LM, Luby M, Butman JA, Demchuk AM, Hill MD, Patronas N, Latour L, Warach S. Magnetic resonance imaging and computed tomography in emergency assessment of patients with suspected acute stroke: a prospective comparison. Lancet. 2007 Jan 27;369(9558):293-8. doi: 10.1016/S0140-6736(07)60151-2.
PubMed 17258669Clark DG, Boan AD, Sims-Robinson C, Adams RJ, Amella EJ, Benitez A, Lackland DT, Ovbiagele B. Differential Impact of Index Stroke on Dementia Risk in African-Americans Compared to Whites. J Stroke Cerebrovasc Dis. 2018 Oct;27(10):2725-2730. doi: 10.1016/j.jstrokecerebrovasdis.2018.05.048. Epub 2018 Aug 1.
PubMed 30076114Douiri A, Rudd AG, Wolfe CD. Prevalence of poststroke cognitive impairment: South London Stroke Register 1995-2010. Stroke. 2013 Jan;44(1):138-45. doi: 10.1161/STROKEAHA.112.670844. Epub 2012 Nov 13.
PubMed 23150656El Husseini N, Katzan IL, Rost NS, Blake ML, Byun E, Pendlebury ST, Aparicio HJ, Marquine MJ, Gottesman RF, Smith EE; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Council on Lifestyle and Cardiometabolic Health. Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association. Stroke. 2023 Jun;54(6):e272-e291. doi: 10.1161/STR.0000000000000430. Epub 2023 May 1.
PubMed 37125534
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Stroke Outcomes: Stroke Resilience, Infarct Burden, and Long-Term Cognition
- ClinicalTrials.gov ID
- NCT06615973
- Acronym / sponsor ID
- 10001861
- Conditions
- Stroke, Brain Disease, Vascular Diseases, Cerebrovascular Disorder
- Keywords
- Stroke, Social Determinants of Health, Cognition, cerebrovascular health, Magnetic Resonance Imaging (MRI), vascular health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Their race
- Education
- Ethnicity
- Employment
- Marital status
- Residence address
- Recent health history
- Medical insurance
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:
- The hospital that first saw the participant at the time of their stroke.
- The type of imaging that was first used then.
- The primary diagnosis at admission.
- Other medical details.
Detailed description
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:
- To characterize SDOH and assess if such characteristics modify the relationship between MRI core infarct volume and post-stroke function (i.e., NIHSS) at baseline and/or discharge. Resilience will thus be assessed by evaluating how specified SDOH modify the correlation between MRI core infarct volume and NIHSS.
- To assess present cognitive function and assess if SDOH modify the relationship between MRI core infarct volume and present-day cognition. Resilience will thus be assessed by evaluating how SDOH modify the correlation between infarct volume and present-day cognition.
- To assess if SDOH modify the relationship between poststroke function (i.e. NIHSS) at baseline and/or discharge with present-day cognition. Resilience will thus be assessed by evaluating how SDOH modify the correlation between NIHSS and present-day cognition.
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.
- Primary Endpoint: Association between MRI core infarct volume and post-stroke function (i.e. NIHSS) as modified by SDOH.
- Secondary Endpoints: Association between MRI core infarct volume and present-day cognitive function as modified by SDOH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Participants who were enrolled in Natural History Study in past 6 years |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Adults aged 18 or older.
- Previous participant in the Natural History of Stroke with an interpretable baseline MRI scan, NIHSS measured at baseline or discharge, and admission diagnosis of ischemic stroke.
- Fluent in English or Spanish
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this
- -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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-stroke function as defined by NIH Stroke Scale (NIHSS)
Time frame: NIHSS and core infarct volume gathered at time of enrollment in Natural History of Stroke study, SDOH gathered at present
Will use linear regression models to assess association between core infarct volume and post stroke function (as defined by NIHSS) as modified by SDOH
1 secondary outcome
Present-day cognitive function
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 28122885Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
- Background: PubMed 17258669Chalela JA, Kidwell CS, Nentwich LM, Luby M, Butman JA, Demchuk AM, Hill MD, Patronas N, Latour L, Warach S. Magnetic resonance imaging and computed tomography in emergency assessment of patients with suspected acute stroke: a prospective comparison. Lancet. 2007 Jan 27;369(9558):293-8. doi: 10.1016/S0140-6736(07)60151-2.
- Background: PubMed 30076114Clark DG, Boan AD, Sims-Robinson C, Adams RJ, Amella EJ, Benitez A, Lackland DT, Ovbiagele B. Differential Impact of Index Stroke on Dementia Risk in African-Americans Compared to Whites. J Stroke Cerebrovasc Dis. 2018 Oct;27(10):2725-2730. doi: 10.1016/j.jstrokecerebrovasdis.2018.05.048. Epub 2018 Aug 1.
- Background: PubMed 23150656Douiri A, Rudd AG, Wolfe CD. Prevalence of poststroke cognitive impairment: South London Stroke Register 1995-2010. Stroke. 2013 Jan;44(1):138-45. doi: 10.1161/STROKEAHA.112.670844. Epub 2012 Nov 13.
- Background: PubMed 37125534El Husseini N, Katzan IL, Rost NS, Blake ML, Byun E, Pendlebury ST, Aparicio HJ, Marquine MJ, Gottesman RF, Smith EE; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Council on Lifestyle and Cardiometabolic Health. Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association. Stroke. 2023 Jun;54(6):e272-e291. doi: 10.1161/STR.0000000000000430. Epub 2023 May 1.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca F Gottesman, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Brain Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca F Gottesman, M.D. ((301) 435-9321, rebecca.gottesman@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-stroke function as defined by NIH Stroke Scale (NIHSS) (time frame: NIHSS and core infarct volume gathered at time of enrollment in Natural History of Stroke study, SDOH gathered at present). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06615973, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.