Assessing Neuroinflammation in GWI Using MRS

NCT04638998 | Completed Results

• 2 other identifiers: IRB-3000004528W81XWH-19-1-0725
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to determine if Gulf War Illness (GWI) likely involves neuroinflammation. The investigators hypothesize that GWI involves neuroinflammation. By assessing the five neuroinflammatory outcomes across the brain, the investigators can determine if there are focal or global signs of one or more neuroinflammatory markers in the brains of individuals with GWI. This neuroimaging technique may allow investigators and others to detect cases of GWI neuroinflammation, which would improve treatment decisions as well as the development of new targeted therapies. It is an ideal diagnostic tool because it has low patient risk, is noninvasive, can be used repeatedly in longitudinal studies, provides whole-brain coverage, yields multiple independent markers of inflammation, and can be employed at most hospitals and research neuroimaging suites.

Conditions

Gulf War Syndrome

Keywords

neuroinflammation; Gulf War Illness

Outcome Measures

Primary Outcomes (5)

• Concentration of Myoinositol in the Brain

  The concentration of myoinositol will be measured in the brain using MRI as a measure of neuroinflammation. This will be measured in both the control and experimental groups.

  20 minutes

• Concentration of Lactate in the Brain

  The concentration of lactate will be measured in the brain using MRI as a measure of neuroinflammation. The concentration will be expressed in water-normed "Institutional Units". This will be measured in both the control and experimental groups. Values are expressed as metabolites averaged across the cortical lobes and cerebellum.

  20 minutes

• Concentration of Choline in the Brain

  The concentration of choline will be measured in the brain using MRI as a measure of neuroinflammation. This will be measured in both the control and experimental groups.

  20 minutes

• Concentration of N-acetylaspartate in the Brain

  The concentration of N-acetylaspartate will be measured in the brain using MRI as a measure of neuroinflammation. This will be measured in both the control and experimental groups.

  20 minutes

• Temperature in the Brain

  The temperature of the brain will be measured using MRI as a measure of neuroinflammation. This will be measured in both the control and experimental groups. An amplitude-weighted combination of NAA, creatine, and choline was used as the reference for temperature deviations.

  20 minutes

Study Arms (2)

Healthy Control

The healthy control group are men ages 46-70 who were present in the Persian Gulf War between 1990 and August 1991. This cohort do not experience any Gulf War Illness symptoms.

Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: Blood draw

Gulf War Illness

The GWI cohort are men ages 46-70 who were present in the Persian Gulf War between 1990 and August 1991. The men in this cohort will also meet the Kansas Inclusion Criteria for GWI.

Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: Blood draw

Interventions

Magnetic Resonance Spectroscopic Imaging PROCEDURE

MRSI is a non invasive imaging technique used to detect neuroinflammation.

Also known as: MRSI

Gulf War Illness; Healthy Control

Blood draw PROCEDURE

Blood will be drawn to assess systemic inflammation in Gulf War verterans.

Gulf War Illness; Healthy Control

Eligibility Criteria

• Age: 46 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study requires the recruitment of Gulf War Veterans who were present in the Persian Gulf between 1990 and August 1991 and who were forward deployed to either Iraq or Kuwait. Of the approximate 650,000 service members who served in the Gulf War, only around 50,000 were women. As the number of female veterans who fit the study criteria wanes in comparison to that of the male veterans, it would prove extremely difficult to recruit both GWI and age-matched, healthy control female veterans. To circumvent this issue, the investigators chose to use only male Gulf War veterans for our study.

You may qualify if:

• Between the ages of 46 and 70
• Present in Persian Gulf between 1990 and August 1991
• Forward deployed (in Iraq or Kuwait)

You may not qualify if:

• Usage of experimental medications, opioid analgesics, psychostimulants (except caffeine), or benzodiazepines
• Uncontrolled diabetes, autoimmune disorders, and thyroid disorders.
• Major cardiovascular illness, cancer, or have any contraindications for MRI (including metallic implants or claustrophobia)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Jones C, Haskin O, Younger J. Neurometabolite alterations in Gulf War Illness: a whole-brain magnetic resonance spectroscopy study. Exp Brain Res. 2025 Oct 25;243(11):237. doi: 10.1007/s00221-025-07174-w.

  PMID: 41137912 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

MeSH Terms

Conditions

Persian Gulf Syndrome; Neuroinflammatory Diseases

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Jarred Younger
• Organization: University of Alabama at Birmingham

youngerlab@uab.edu

205-975-5821

Study Officials

• Jarred Younger, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: December 1, 2020
• Primary Completion: September 29, 2023
• Study Completion: December 31, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-11

Locations

US (1)