Brain Health Oneida

NCT07080866 | Completed DMC FDA Device

• 4 other identifiers: 2025-1005A535700SMPH/NEURO SURG/NEURO SURGProtocol Version 9/22/2025
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Oneida Nation Members

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  3 months

Secondary Outcomes (1)

• Brain connectivity

  3 months

Study Arms (1)

Oneida Nation

Participants will be Native American and undergo MRI an ultrasound

Diagnostic Test: MRI; Diagnostic Test: Carotid ultrasound

Interventions

MRI DIAGNOSTIC_TEST

Participants will undergo a 60-minute MRI

Oneida Nation

Carotid ultrasound DIAGNOSTIC_TEST

Participants will undergo an ultrasound

Oneida Nation

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of the Oneida Nation reservation

You may qualify if:

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

You may not qualify if:

• Not Native American
• Contraindications to MRI scans

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (2)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Oneida Nation Reservation

Oneida, Wisconsin, 54155, United States

Location

MeSH Terms

Interventions

Ultrasonography, Carotid Arteries

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Robert Dempsey, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: September 2, 2025
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)