Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
70 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-05-16
Study Completion Date
2026-06-30
Brief Summary
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Brain blood flow regulation and autonomic dysfunction will be measured in Veterans with and without Gulf War Illness who served in the Gulf War between 1990 and 1992.
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Detailed Description
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Gulf War Illness (GWI) is a multi-symptom illness with unknown etiology. GWI is a leading cause of disability in Gulf War Veterans. Cognitive complaints are a common symptom of GWI, which suggests the brain is involved in the development of this condition. As Veterans age, these cognitive complaints may worsen and be compounded by the aging process. GWI may be a condition of "accelerated" brain aging. Therefore, there may be long-term consequences of GWI, and the presence of GWI may increase a person's risk for developing Alzheimer's Disease (AD) or other dementias. In comparison to other brain-related diseases such as stroke, relatively little is known about GWI and how this condition impacts the normal age-related changes in the brain.
The research aims are:
1. To determine if Veterans with Gulf War Illness demonstrate abnormal brain blood flow regulation and autonomic dysfunction when compared with Veterans without Gulf War Illness.
2. To determine if brain blood flow and autonomic nervous system variables in Veterans are associated with other markers of brain aging that are relevant to cognitive decline.
The research aims are:
1. To determine if Veterans with Gulf War Illness demonstrate abnormal brain blood flow regulation and autonomic dysfunction when compared with Veterans without Gulf War Illness.
2. To determine if brain blood flow and autonomic nervous system variables in Veterans are associated with other markers of brain aging that are relevant to cognitive decline.
Conditions
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Brain Blood Flow
Neurovascular Control
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Veterans with GWI
Veterans with GWI who served in the Gulf War between 1990 and 1992
MRI
Intervention Type
DEVICE
Participants will undergo an MRI scan while participating in a breathing test to measure brain blood flow.
Transcranial Doppler Ultrasound
Intervention Type
DEVICE
Participants will undergo a TCD scan while participating in a breathing test to measure brain blood flow.
Sympathetic Nerve Activity
Intervention Type
OTHER
Participants will undergo sympathetic nerve activity testing while participating in a breathing test.
Veterans without GWI (Controls)
Veterans without GWI who served in the Gulf War between 1990 and 1992
MRI
Intervention Type
DEVICE
Participants will undergo an MRI scan while participating in a breathing test to measure brain blood flow.
Transcranial Doppler Ultrasound
Intervention Type
DEVICE
Participants will undergo a TCD scan while participating in a breathing test to measure brain blood flow.
Sympathetic Nerve Activity
Intervention Type
OTHER
Participants will undergo sympathetic nerve activity testing while participating in a breathing test.
Interventions
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MRI
Participants will undergo an MRI scan while participating in a breathing test to measure brain blood flow.
Intervention Type
DEVICE
Transcranial Doppler Ultrasound
Participants will undergo a TCD scan while participating in a breathing test to measure brain blood flow.
Intervention Type
DEVICE
Sympathetic Nerve Activity
Participants will undergo sympathetic nerve activity testing while participating in a breathing test.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Deployed to the Persian Gulf between 1990-1992
* Body mass \<300 lbs
* Diagnosis of Gulf War Illness based on CMI/CDC and Kansas definitions or No diagnosis of Gulf War Illness
* Body mass \<300 lbs
* Diagnosis of Gulf War Illness based on CMI/CDC and Kansas definitions or No diagnosis of Gulf War Illness
Exclusion Criteria
* Current or lifetime evidence of: Type II diabetes, neurological disease, cancer treatment, rheumatoid arthritis, lupus, bipolar disorder, psychotic disorders, or mood disorders with psychotic features
* Current illicit substance use or partial remission for less than 1 year
* Taking multiple sedatives or anticonvulsant medications
* Currently pregnant
* Absolute contraindications to exercise testing
* Contraindications to MRI
* Other significant medical conditions at investigator's discretion
* Current illicit substance use or partial remission for less than 1 year
* Taking multiple sedatives or anticonvulsant medications
* Currently pregnant
* Absolute contraindications to exercise testing
* Contraindications to MRI
* Other significant medical conditions at investigator's discretion
Minimum Eligible Age
45 Years
Maximum Eligible Age
68 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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United States Department of Defense
FED
Sponsor Role
collaborator
University of Wisconsin, Madison
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jill N Barnes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin-Madison
Madison, Wisconsin, United States
Site Status
Countries
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United States
References
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Other Identifiers
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A176000
Identifier Type: OTHER
Identifier Source: secondary_id
EDUC/KINESIOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
W81XWH1910381
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Protocol Version 09/15/2021
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0961
Identifier Type: -
Identifier Source: org_study_id
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