Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-31 @ 1:56 AM
Study NCT ID:
NCT07080866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Health Oneida
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092262', 'term': 'Ultrasonography, Carotid Arteries'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortical thickness', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'White matter lesion buildup', 'timeFrame': '3 months', 'description': 'Buildup is measured using T2-FLAIR White Matter Hyperintensities (WMHs). Number and extent of WMHs is normalized based on head size.'}, {'measure': 'Number of strokes', 'timeFrame': '3 months', 'description': 'Imaging helps assess number of strokes, understanding the type of stroke, underlying causes for stroke, identification of vascular malformations, treatment planning and outcomes prediction.'}, {'measure': 'Microstructural integrity', 'timeFrame': '3 months', 'description': "DTI (Diffusion Tensor Imaging) visualizes the structure of the brain's white matter. It helps understand how brain regions are connected."}, {'measure': 'Cerebral blood flow', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Atherosclerotic vascular buildup', 'timeFrame': '3 months', 'description': 'Atherosclerotic vascular buildup is measured using 4Dflow MRA imaging. This technique allows for a more detailed visualization and quantification of blood flow patterns.'}], 'secondaryOutcomes': [{'measure': 'Brain connectivity', 'timeFrame': '3 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Oneida Nation Members']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants will undergo:\n\n* Carotid ultrasound\n* Magnetic resonance imaging (MRI)\n* Cognitive testing', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of the Oneida Nation reservation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55-90\n* Receiving healthcare though the Oneida Comprehensive Health Division\n\nExclusion Criteria:\n\n* Not Native American\n* Contraindications to MRI scans'}, 'identificationModule': {'nctId': 'NCT07080866', 'briefTitle': 'Brain Health Oneida', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Brain Health and Root Causes of Stroke Risk Disparity in Wisconsin Native Americans', 'orgStudyIdInfo': {'id': '2025-1005'}, 'secondaryIdInfos': [{'id': 'A535700', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/NEURO SURG/NEURO SURG', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 9/22/2025', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oneida Nation', 'description': 'Participants will be Native American and undergo MRI an ultrasound', 'interventionNames': ['Diagnostic Test: MRI', 'Diagnostic Test: Carotid ultrasound']}], 'interventions': [{'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo a 60-minute MRI', 'armGroupLabels': ['Oneida Nation']}, {'name': 'Carotid ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo an ultrasound', 'armGroupLabels': ['Oneida Nation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '54155', 'city': 'Oneida', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Oneida Nation Reservation', 'geoPoint': {'lat': 44.4986, 'lon': -88.18288}}], 'overallOfficials': [{'name': 'Robert Dempsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}