Trial Outcomes & Findings for Assessing Neuroinflammation in GWI Using MRS (NCT NCT04638998)
NCT ID: NCT04638998
Last Updated: 2025-01-13
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
49 participants
Primary outcome timeframe
20 minutes
Results posted on
2025-01-13
Participant Flow
Participant milestones
| Measure |
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
28
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Assessing Neuroinflammation in GWI Using MRS
Baseline characteristics by cohort
| Measure |
Healthy Control
n=21 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
Gulf War Illness
n=28 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
28 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 minutesPopulation: Some participants data were excluded due to poor quality
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.
Outcome measures
| Measure |
Healthy Control
n=19 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
Gulf War Illness
n=20 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
|---|---|---|
|
Concentration of Myoinositol in the Brain
|
0.001260 Institutional Units (IU)
Standard Deviation 0.0002362
|
0.001205 Institutional Units (IU)
Standard Deviation 0.0001699
|
PRIMARY outcome
Timeframe: 20 minutesPopulation: Some participants data were excluded due to poor quality
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.
Outcome measures
| Measure |
Healthy Control
n=19 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
Gulf War Illness
n=20 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
|---|---|---|
|
Concentration of Lactate in the Brain
|
0.0003886 Institutional Units (IU)
Standard Deviation 0.0001629
|
0.0005388 Institutional Units (IU)
Standard Deviation 0.000365
|
PRIMARY outcome
Timeframe: 20 minutesPopulation: Some participants data were excluded due to poor quality
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.
Outcome measures
| Measure |
Healthy Control
n=19 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
Gulf War Illness
n=20 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
|---|---|---|
|
Concentration of Choline in the Brain
|
0.0003838 Institutional Units (IU)
Standard Deviation 0.000051446
|
0.0003499 Institutional Units (IU)
Standard Deviation 0.000034982
|
PRIMARY outcome
Timeframe: 20 minutesPopulation: Some participants data were excluded due to poor quality
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.
Outcome measures
| Measure |
Healthy Control
n=19 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
Gulf War Illness
n=20 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
|---|---|---|
|
Concentration of N-acetylaspartate in the Brain
|
0.0023191 Institutional Units (IU)
Standard Deviation 0.0001821
|
0.0022186 Institutional Units (IU)
Standard Deviation 0.0001721
|
PRIMARY outcome
Timeframe: 20 minutesThe 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.
Outcome measures
| Measure |
Healthy Control
n=19 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
Gulf War Illness
n=20 Participants
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.
Magnetic Resonance Spectroscopic Imaging: MRSI is a non invasive imaging technique used to detect neuroinflammation.
Blood draw: Blood will be drawn to assess systemic inflammation in Gulf War verterans.
|
|---|---|---|
|
Temperature in the Brain
|
36.622 degrees Celsius
Standard Deviation 0.322
|
36.826 degrees Celsius
Standard Deviation 0.331
|
Adverse Events
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gulf War Illness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place