Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular and Neurovascular Regulation in GWI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586049
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Wisconsin, Madison

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 1991.

Condition or disease Intervention/treatment
Brain Blood Flow Neurovascular Control Device: MRI Device: Transcrainal Doppler Ultrasound Other: Sympathetic Nerve Activity

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.

Layout table for study information
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 : December 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Group/Cohort Intervention/treatment
Veterans with GWI
Veterans with GWI who served in the Gulf War between 1990 and 1991
Device: MRI
Participants will undergo an MRI scan while participating in a breathing test to measure brain blood flow.

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

Device: Transcrainal 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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:

  • History or evidence of: diabetes, neurological disease, cancer treatment, rheumatoid arthritis, lupus, bipolar disorder, psychotic disorders, mood disorders
  • 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Jill N Barnes, PhD 608-262-1654 jnbarnes@wisc.edu
Contact: Anna J Howery, MS 608-262-9572 barneslab@education.wisc.edu

Sponsors and Collaborators
University of Wisconsin, Madison
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Jill N Barnes, PhD University of Wisconsin, Madison
Publications:
Institute of Medicine. 2013. Gulf War and Health: Treatment for Chronic Multisymptom Illness. Washington, DC: The National Academies Press. https://doi.org/10.17226/13539.

Layout table for additonal information
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 9/8/2020 ( Other Identifier: UW Madison )
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
MRI
Brain Blood Flow
Sympathetic Nerve Activity
Cardiorespiratory Fitness