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OpenTrials
Completed

NCT Number: NCT07080866

Brain Health Oneida

The purpose of this observational study is to better understand the relationship between stroke risk factors and brain MRI measures in the Native American population.

Participants will undergo:

* Carotid ultrasound * Magnetic resonance imaging (MRI) * Cognitive testing

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Key information

Conditions

Oneida Nation Members

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin - Madison, Madison, Wisconsin, United States

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About this study

Researchers' central hypothesis is that Native Americans (NAs) suffer from chronic psychological stress (PS) and inter-generational trauma related to historical loss (HL) which are manifested as inflammatory proteomic changes, leading to atherosclerotic vessel wall injury, stroke and vascular cognitive impairment (VCI). The researchers present a study to determine if MRI brain health metrics such as structural and functional connections, cerebral blood flow measures, brain morphometry are correlated with cardiovascular risk factors, atherosclerotic disease burden, blood inflammatory proteins, and scores on the Oneida cultural nutritional programs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 55-90
  • Receiving healthcare though the Oneida Comprehensive Health Division

Exclusion criteria

  • Not Native American
  • Contraindications to MRI scans

Treatment and study plan

MRI

Diagnostic Test

Participants will undergo a 60-minute MRI

Carotid ultrasound

Diagnostic Test

Participants will undergo an ultrasound

Primary outcomes

  1. Cortical thickness

    Time frame: 3 months

    Cortical thickness is measured using T1w MRI imaging. Normal thickness is 1-4.55mm - average is about 2.5mm, below that range is considered thinning.

  2. White matter lesion buildup

    Time frame: 3 months

    Buildup is measured using T2-FLAIR White Matter Hyperintensities (WMHs). Number and extent of WMHs is normalized based on head size.

  3. Number of strokes

    Time frame: 3 months

    Imaging helps assess number of strokes, understanding the type of stroke, underlying causes for stroke, identification of vascular malformations, treatment planning and outcomes prediction.

  4. Microstructural integrity

    Time frame: 3 months

    DTI (Diffusion Tensor Imaging) visualizes the structure of the brain's white matter. It helps understand how brain regions are connected.

  5. Cerebral blood flow

    Time frame: 3 months

    Cerebral blood flow is measured using ASL perfusion MRI imaging. This technique provides quantitative measure of blood flow to brain tissue, which allows to assess brain function.

  6. Atherosclerotic vascular buildup

    Time frame: 3 months

    Atherosclerotic vascular buildup is measured using 4Dflow MRA imaging. This technique allows for a more detailed visualization and quantification of blood flow patterns.

Secondary outcomes

  1. Brain connectivity

    Time frame: 3 months

    Brain functional connectivity is measured using resting functional MRI. Those participants with fewer cerebrovascular disease (CVD) risk factors will resemble expected connectivity of healthy adults, compared to those with CVD risk factors will be significantly different.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Brain Health and Root Causes of Stroke Risk Disparity in Wisconsin Native Americans

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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