Cardiovascular and Neurovascular Regulation in GWI

September 22, 2023 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Veterans with GWI
Veterans with GWI who served in the Gulf War between 1990 and 1992
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 1992
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Jill N Barnes, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-0961
  • A176000 (Other Identifier: University of Wisconsin, Madison)
  • EDUC/KINESIOLOGY (Other Identifier: UW Madison)
  • W81XWH1910381 (Other Grant/Funding Number: Department of Defense)
  • Protocol Version 09/15/2021 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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