Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-03 @ 8:36 PM
Study NCT ID:
NCT07080866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Health Oneida
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Brain Health and Root Causes of Stroke Risk Disparity in Wisconsin Native Americans
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: