Cardiovascular and Neurovascular Regulation in GWI
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ClinicalTrials.gov Identifier: NCT04586049 |
Recruitment Status :
Recruiting
First Posted : October 14, 2020
Last Update Posted : January 26, 2023
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Condition or disease | Intervention/treatment |
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Brain Blood Flow Neurovascular Control | Device: MRI Device: Transcranial Doppler Ultrasound Other: Sympathetic Nerve Activity |
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:
- 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.
- 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.
Study Type : | Observational |
Estimated Enrollment : | 70 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Autonomic Dysfunction, Brain Blood Flow and Cognitive Decline in Veterans With Gulf War Illness |
Estimated Study Start Date : | March 2023 |
Estimated Primary Completion Date : | September 2024 |
Estimated Study Completion Date : | September 2024 |
Group/Cohort | Intervention/treatment |
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Veterans with GWI
Veterans with GWI who served in the Gulf War between 1990 and 1991
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Device: MRI
Participants will undergo an MRI scan while participating in a breathing test to measure brain blood flow. Device: Transcranial Doppler Ultrasound Participants will undergo a TCD scan while participating in a breathing test to measure brain blood flow. Other: Sympathetic Nerve Activity 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 1991
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Device: MRI
Participants will undergo an MRI scan while participating in a breathing test to measure brain blood flow. Device: Transcranial Doppler Ultrasound Participants will undergo a TCD scan while participating in a breathing test to measure brain blood flow. Other: Sympathetic Nerve Activity Participants will undergo sympathetic nerve activity testing while participating in a breathing test. |
- Brain blood flow measured using Transcranial Doppler ultrasound [ Time Frame: Baseline ]Neurovascular control will be investigated by measuring the change in brain blood flow using a transcranial Doppler ultrasound in response to a breathing test.
- Brain blood flow measured using MRI [ Time Frame: Baseline ]Neurovascular control will be investigated by measuring the change in brain blood flow using an MRI in response to a breathing test.
- Sympathetic nerve activity [ Time Frame: Baseline ]Neurovascular control will be investigated by measuring the change in sympathetic nerve activity will be measured using microneurography in response to a breathing test.

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Ages Eligible for Study: | 45 Years to 68 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Deployed to the Persian Gulf between 1990-1991
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586049
Contact: Jill N Barnes, PhD | 608-262-1654 | jnbarnes@wisc.edu | |
Contact: Anna J Howery, MS | 608-262-9572 | barneslab@education.wisc.edu |
United States, Wisconsin | |
University of Wisconsin-Madison | Recruiting |
Madison, Wisconsin, United States, 53706 | |
Contact: Anna Howery, MS 608-262-9572 barneslab@education.wisc.edu |
Principal Investigator: | Jill N Barnes, PhD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT04586049 |
Other Study ID Numbers: |
2019-0961 A176000 ( Other Identifier: UW Madison ) EDUC/KINESIOLOGY ( Other Identifier: UW Madison ) W81XWH1910381 ( Other Grant/Funding Number: Department of Defense ) Protocol Version 09/15/2021 ( Other Identifier: UW Madison ) |
First Posted: | October 14, 2020 Key Record Dates |
Last Update Posted: | January 26, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
MRI Brain Blood Flow Sympathetic Nerve Activity Cardiorespiratory Fitness |