Recruiting

Observational Study

Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Code:

NCT06615973

Conditions

Stroke

Brain Disease

Vascular Diseases

Cerebrovascular Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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.

Conditions

Stroke

Brain Disease

Vascular Diseases

Cerebrovascular Disorder

Study ID

NCT06615973

Start date

Sep 14, 2026

Status verified date

May 28, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

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

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).

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients

Participants who were enrolled in Natural History Study in past 6 years

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 ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Last update posted

Sep 9, 2026

Last verified

May 28, 2026

Keywords

  • Stroke
  • Social Determinants of Health
  • Cognition
  • cerebrovascular health
  • Magnetic Resonance Imaging (MRI)
  • vascular health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS) on 2026-09-09.