N/A
N=49
Assessing Neuroinflammation in GWI Using MRS
Gulf War Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04638998 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Concentration of Myoinositol in the Brain — 0.001260; 0.001205 Institutional Units (IU)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Magnetic Resonance Spectroscopic Imaging (Procedure); Blood draw (Procedure)
- Age
- Adult, Older Adult · 46+ yrs
- Sex
- Male
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Myoinositol in the Brain |
0.001260; 0.001205 | — |
| PRIMARY Concentration of Lactate in the Brain |
0.0003886; 0.0005388 | — |
| PRIMARY Concentration of Choline in the Brain |
0.0003838; 0.0003499 | — |
| PRIMARY Concentration of N-acetylaspartate in the Brain |
0.0023191; 0.0022186 | — |
| PRIMARY Temperature in the Brain |
36.622; 36.826 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Between the ages of 46 and 70
- Veterans who meet the Kansas inclusion criteria .The Kansas Inclusion Criteria are a set of the most frequently reported symptoms experienced by Gulf War veterans. This frequency and severity of the symptoms reported by the participant indicate whether the person has Gulf War Illness or not. The Kansas Inclusion Criteria is the gold standard for identifying veterans with GWI in the field. The criteria are attached.
- Present in Persian Gulf between 1990 and August 1991
- Forward deployed (in Iraq or Kuwait)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04638998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.