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Brain Blood FlowNCT04586049

Cardiovascular and Neurovascular Regulation in GWI

An observational study of Brain Blood Flow and Neurovascular Control, run by University of Wisconsin, Madison at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 45 to 68 yearsHealthy volunteers can take part
Conditions the study is for
Brain Blood Flow, Neurovascular Control
What is being tested?
MRI, Transcranial Doppler Ultrasound and Sympathetic Nerve Activity
Type of treatment
Medical device
How many people
70 participants
Where
1 siteUnited States
Study dates
16 May 2023to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 68 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects for this study will include Veterans with Gulf War Illness and Veterans without Gulf War Illness. Both men and women are eligible to participate in this study.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: Autonomic Dysfunction, Brain Blood Flow and Cognitive Decline in Veterans With Gulf War Illness

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.

Read the detailed description

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.
Being tested
MRI, Transcranial Doppler Ultrasound, Sympathetic Nerve Activity
Keywords
MRI, Brain Blood Flow, Sympathetic Nerve Activity, Cardiorespiratory Fitness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDevice

    Participants will undergo an MRI scan while participating in a breathing test to measure brain blood flow.

  • Transcranial Doppler UltrasoundDevice

    Participants will undergo a TCD scan while participating in a breathing test to measure brain blood flow.

  • Sympathetic Nerve ActivityOther

    Participants will undergo sympathetic nerve activity testing while participating in a breathing test.

Study groups in NCT04586049
Study groupRoleWhat they receive
Veterans with GWIVeterans with GWI who served in the Gulf War between 1990 and 1992
Receives: Device: MRI; Device: Transcranial Doppler Ultrasound; Other: Sympathetic Nerve Activity
Veterans without GWI (Controls)Veterans without GWI who served in the Gulf War between 1990 and 1992
Receives: Device: MRI; Device: Transcranial Doppler Ultrasound; Other: Sympathetic Nerve Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brain blood flow measured using Transcranial Doppler ultrasound

    Neurovascular control will be investigated by measuring the change in brain blood flow using a transcranial Doppler ultrasound in response to a breathing test.

    Measured: Baseline

  2. Brain blood flow measured using MRI

    Neurovascular control will be investigated by measuring the change in brain blood flow using an MRI in response to a breathing test.

    Measured: Baseline

  3. Sympathetic nerve activity

    Neurovascular control will be investigated by measuring the change in sympathetic nerve activity will be measured using microneurography in response to a breathing test.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start16 May 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586049
Sponsor's protocol ID
2019-0961
Other IDs
A176000, EDUC/KINESIOLOGY, W81XWH1910381, Protocol Version 09/15/2021
Status last verified
Jun 2026
First submitted
6 Oct 2020
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lecrux C, Hamel E. The neurovascular unit in brain function and disease. Acta Physiol (Oxf). 2011 Sep;203(1):47-59. doi: 10.1111/j.1748-1716.2011.02256.x. Epub 2011 Mar 22.

    PubMed 21272266

  • Catchlove SJ, Parrish TB, Chen Y, Macpherson H, Hughes ME, Pipingas A. Regional Cerebrovascular Reactivity and Cognitive Performance in Healthy Aging. J Exp Neurosci. 2018 Jul 5;12:1179069518785151. doi: 10.1177/1179069518785151. eCollection 2018.

    PubMed 30013388

  • Lange G, Tiersky LA, Scharer JB, Policastro T, Fiedler N, Morgan TE, Natelson BH. Cognitive functioning in Gulf War Illness. J Clin Exp Neuropsychol. 2001 Apr;23(2):240-9. doi: 10.1076/jcen.23.2.240.1208.

    PubMed 11309677

  • Toomey R, Alpern R, Vasterling JJ, Baker DG, Reda DJ, Lyons MJ, Henderson WG, Kang HK, Eisen SA, Murphy FM. Neuropsychological functioning of U.S. Gulf War veterans 10 years after the war. J Int Neuropsychol Soc. 2009 Sep;15(5):717-29. doi: 10.1017/S1355617709990294. Epub 2009 Jul 29.

    PubMed 19640317

  • Bunegin L, Mitzel HC, Miller CS, Gelineau JF, Tolstykh GP. Cognitive performance and cerebrohemodynamics associated with the Persian Gulf Syndrome. Toxicol Ind Health. 2001 May;17(4):128-37. doi: 10.1191/0748233701th100oa.

    PubMed 12479508

  • Hubbard NA, Hutchison JL, Motes MA, Shokri-Kojori E, Bennett IJ, Brigante RM, Haley RW, Rypma B. Central Executive Dysfunction and Deferred Prefrontal Processing in Veterans with Gulf War Illness. Clin Psychol Sci. 2014 May 1;2(3):319-327. doi: 10.1177/2167702613506580.

    PubMed 25767746

  • Christova P, James LM, Engdahl BE, Lewis SM, Carpenter AF, Georgopoulos AP. Subcortical brain atrophy in Gulf War Illness. Exp Brain Res. 2017 Sep;235(9):2777-2786. doi: 10.1007/s00221-017-5010-8. Epub 2017 Jun 20.

    PubMed 28634886

  • Chao LL, Rothlind JC, Cardenas VA, Meyerhoff DJ, Weiner MW. Effects of low-level exposure to sarin and cyclosarin during the 1991 Gulf War on brain function and brain structure in US veterans. Neurotoxicology. 2010 Sep;31(5):493-501. doi: 10.1016/j.neuro.2010.05.006. Epub 2010 May 24.

    PubMed 20580739

  • Van Riper SM, Alexander AL, Koltyn KF, Stegner AJ, Ellingson LD, Destiche DJ, Dougherty RJ, Lindheimer JB, Cook DB. Cerebral white matter structure is disrupted in Gulf War Veterans with chronic musculoskeletal pain. Pain. 2017 Dec;158(12):2364-2375. doi: 10.1097/j.pain.0000000000001038.

    PubMed 28796115

  • Pop V, Sorensen DW, Kamper JE, Ajao DO, Murphy MP, Head E, Hartman RE, Badaut J. Early brain injury alters the blood-brain barrier phenotype in parallel with beta-amyloid and cognitive changes in adulthood. J Cereb Blood Flow Metab. 2013 Feb;33(2):205-14. doi: 10.1038/jcbfm.2012.154. Epub 2012 Nov 14.

    PubMed 23149553

  • Ikonomovic MD, Mi Z, Abrahamson EE. Disordered APP metabolism and neurovasculature in trauma and aging: Combined risks for chronic neurodegenerative disorders. Ageing Res Rev. 2017 Mar;34:51-63. doi: 10.1016/j.arr.2016.11.003. Epub 2016 Nov 6.

    PubMed 27829172

  • Johnson VE, Stewart W, Smith DH. Traumatic brain injury and amyloid-beta pathology: a link to Alzheimer's disease? Nat Rev Neurosci. 2010 May;11(5):361-70. doi: 10.1038/nrn2808.

    PubMed 20216546

  • Barnes JN. Exercise, cognitive function, and aging. Adv Physiol Educ. 2015 Jun;39(2):55-62. doi: 10.1152/advan.00101.2014.

    PubMed 26031719

  • Barnes JN, Schmidt JE, Nicholson WT, Joyner MJ. Cyclooxygenase inhibition abolishes age-related differences in cerebral vasodilator responses to hypercapnia. J Appl Physiol (1985). 2012 Jun;112(11):1884-90. doi: 10.1152/japplphysiol.01270.2011. Epub 2012 Mar 22.

    PubMed 22442028

  • Coverdale NS, Badrov MB, Shoemaker JK. Impact of age on cerebrovascular dilation versus reactivity to hypercapnia. J Cereb Blood Flow Metab. 2017 Jan;37(1):344-355. doi: 10.1177/0271678X15626156. Epub 2016 Jan 12.

    PubMed 26759432

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Blood Flow and Neurovascular Control, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain blood flow measured using Transcranial Doppler ultrasound (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04586049, which also lists 51 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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