Oneida Nation MembersNCT07080866
Brain Health Oneida
An observational study of Oneida Nation Members, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Oneida Nation Members
- What is being tested?
- MRI and Carotid ultrasound
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Sep 2025to 23 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents of the Oneida Nation reservation
Who may be able to join
- Age 55-90
- Receiving healthcare though the Oneida Comprehensive Health Division
Who cannot join
- Not Native American
- Contraindications to MRI scans
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Oneida Nation Reservation
Oneida, Wisconsin, 54155
About this study
Official title: Brain Health and Root Causes of Stroke Risk Disparity in Wisconsin Native Americans
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
Read the detailed description
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.
- Conditions
- Oneida Nation Members
- Being tested
- MRI, Carotid ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Participants will undergo a 60-minute MRI
Carotid ultrasoundDiagnostic test
Participants will undergo an ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Oneida Nation | Participants will be Native American and undergo MRI an ultrasound Receives: Diagnostic Test: MRI; Diagnostic Test: Carotid ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical thickness
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.
Measured: 3 months
White matter lesion buildup
Buildup is measured using T2-FLAIR White Matter Hyperintensities (WMHs). Number and extent of WMHs is normalized based on head size.
Measured: 3 months
Number of strokes
Imaging helps assess number of strokes, understanding the type of stroke, underlying causes for stroke, identification of vascular malformations, treatment planning and outcomes prediction.
Measured: 3 months
Microstructural integrity
DTI (Diffusion Tensor Imaging) visualizes the structure of the brain's white matter. It helps understand how brain regions are connected.
Measured: 3 months
Cerebral blood flow
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.
Measured: 3 months
Atherosclerotic vascular buildup
Atherosclerotic vascular buildup is measured using 4Dflow MRA imaging. This technique allows for a more detailed visualization and quantification of blood flow patterns.
Measured: 3 months
Secondary outcomes (1)
Brain connectivity
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start2 Sep 2025
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oneida Nation MembersStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Dempsey, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080866
- Sponsor's protocol ID
- 2025-1005
- Other IDs
- A535700, SMPH/NEURO SURG/NEURO SURG, Protocol Version 9/22/2025
- Status last verified
- Feb 2026
- First submitted
- 15 Jul 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Health and Root Causes of Stroke Risk Disparity in Wisconsin Native Americans
- ClinicalTrials.gov ID
- NCT07080866
- Acronym / sponsor ID
- 2025-1005
- Conditions
- Oneida Nation Members
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 23 Jul 2025 (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.
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
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oneida Nation | – | Diagnostic Test: MRI, Diagnostic Test: Carotid ultrasoundParticipants will be Native American and undergo MRI an ultrasound |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of the Oneida Nation reservation
Key inclusion criteria (2 listed)
- Age 55-90
- Receiving healthcare though the Oneida Comprehensive Health Division
Key exclusion criteria (2 listed)
- Not Native American
- Contraindications to MRI scans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIParticipants will undergo a 60-minute MRI | Diagnostic test | Oneida Nation |
| Carotid ultrasoundParticipants will undergo an ultrasound | Diagnostic test | Oneida Nation |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
Brain connectivity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Oneida Nation Members
Recruiting
The AHA Oneida Study
Oneida Nation Members
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. This study is not recruiting at the moment.
Robert Dempsey, MD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oneida Nation Members, run by University of Wisconsin, Madison at 2 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical thickness (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.