Actively Recruiting
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-07
85
Participants Needed
1
Research Sites
402 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Gulf War illness (GWI) affects up to 210,000 U.S. veterans who served in the Middle East during the Gulf War in 1990-1991. Symptoms include fatigue, muscle and joint pain, forgetfulness, headaches, rashes, and sleep disturbances. Routine exams cannot determine the cause of GWI. Researchers need more information to understand this disease. Objective: This natural history study will look for differences in Gulf War veterans who experienced GWI and those who did not. Eligibility: Gulf War veterans with GWI. Healthy Gulf War veterans who do not have GWI are also needed. Design: Participants will stay in the NIH Clinical Center as an inpatient for 2 weeks. They will undergo many tests. Blood will be drawn many times throughout the study. Participants will also give urine, saliva, and stool samples. Scans to measure the brain, leg muscles, bone density and body mass will be done. They will have an exercise stress test and muscle strength tests. They will have a sleep study. They will have tests to look at how well the brain, heart and lungs are working. Participants will sleep in a specialized room that measures the amount of oxygen they use and the carbon dioxide they produce on four consecutive nights. A sample of fluid will be collected from inside the spine. Participants will take many surveys. Some will ask about their activities. Some will be about emotional and mental health. Some will be about thinking, memory, and behavior. Optional tests include other imaging scans and testing the autonomic nervous system. Samples of skin and muscle may be taken. After discharge, participants will wear activity monitors for 14 days. They will keep a diary of their symptoms, including fatigue, pain, and sleep, while wearing the monitors....
CONDITIONS
Official Title
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent
- Willingness to comply with all study procedures and availability for the study duration
- Age between 48 and 70 years at enrollment
- Veterans deployed to the Gulf Region between August 1990 and June 1991
- Completion of at least seventh grade education
- Fluency in speaking, reading, and understanding English
- Eligible as determined by the VA IN-DEPTH Adjudication Committee
- Agree not to smoke within 4 hours prior to the exercise test (CPET)
You will not qualify if you...
- Current or past psychotic disorders, including depression with psychosis, bipolar disorder with psychotic symptoms, and schizophrenia
- Current major depression, generalized anxiety disorder, PTSD, panic disorder, or OCD unless stable and treated for over six months
- Substance use disorder within past five years (excluding prior or prescription marijuana use)
- Current suicidal thoughts
- History of moderate or severe traumatic brain injury; mild traumatic brain injury allowed
- Pregnancy, breastfeeding, or within one year postpartum
- Current or previous malignancy except fully resolved by surgery alone
- Current systemic immunologic disorders (e.g., Type 1 diabetes, rheumatoid arthritis); local or allergic disorders allowed
- Current or previous long-term immune suppressive therapy; no systemic steroids within one month prior
- Medical conditions making study procedures risky (e.g., heart failure, coronary artery disease, COPD, severe osteoarthritis, exercise-induced angina, poorly controlled asthma)
- Participation in other clinical protocols affecting study results
- Inability to perform the bicycling exercise task
- Unwillingness to allow broad sharing of research data and samples
- Severe symptoms preventing travel or extended inpatient stay
- Use of medications with high withdrawal risk (e.g., long-acting opiates or benzodiazepines)
- For TMS testing: pacemakers, implants, metal in eye/skull, history of seizure disorder
- For MRI testing: unsafe metal in body, claustrophobia, inability to lie still for up to 2 hours
- Healthy controls must not meet modified Kansas criteria for GWI
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Angelique A Gavin
CONTACT
B
Brian T Walitt, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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