Cardiovascular and Neurovascular Regulation in GWI

NCT04586049 | Active Not Recruiting

• 5 other identifiers: 2019-0961A176000EDUC/KINESIOLOGYW81XWH1910381Protocol Version 09/15/2021
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Blood Flow; Neurovascular Control

Keywords

MRI; Brain Blood Flow; Sympathetic Nerve Activity; Cardiorespiratory Fitness

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

Study Arms (2)

Veterans with GWI

Veterans with GWI who served in the Gulf War between 1990 and 1992

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

Device: MRI; Device: Transcranial Doppler Ultrasound; Other: Sympathetic Nerve Activity

Interventions

MRI DEVICE

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

Veterans with GWI; Veterans without GWI (Controls)

Transcranial Doppler Ultrasound DEVICE

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

Veterans with GWI; Veterans without GWI (Controls)

Sympathetic Nerve Activity OTHER

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

Veterans with GWI; Veterans without GWI (Controls)

Eligibility Criteria

• Age: 45 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

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MeSH Terms

Interventions

Ultrasonography, Doppler, Transcranial

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Jill N Barnes, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: May 16, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)