RECRUITING

NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)

Talk to us

Conditions

Gulf War IllnessVeteranGwi (Gulf War Illness)Natural History

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)

Quick Facts

Study Start:2023-04-16
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05375812

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:48 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide informed consent
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Age 48-70 at time of enrollment into VA IN-DEPTH Study
  4. * Veterans who were deployed to Gulf Region ODS/S between August 1990 - June 1991.
  5. * Self-reported completion of at least the seventh grade of school.
  6. * Fluency in speaking, reading, and understanding English.
  7. * Underwent screening as part of the VA IN-DEPTH study and were unanimously determined to be eligible by the IN-DEPTH Adjudication Committee.
  8. * Agree not to smoke in the 4 hours prior to CPET procedure
  1. * Current or past psychotic disorder including depression with psychosis, bipolar disorder with psychotic symptoms and schizophrenia
  2. * Current DSM-5-defined major depression disorder, generalized anxiety disorder, posttraumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen
  3. * Current or past substance use disorder within last five years as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5). Prior or prescription marijuana use within the past five years will not be an exclusion.
  4. * Current suicidal ideation
  5. * History of head injury leading to moderate or severe traumatic brain injury, as detailed by loss of consciousness for greater than 30 minutes, a Glasgow Coma Score of 12 or less at the time of injury, post-traumatic amnesia greater than one day, or brain-scan changes related to a head injury. Persons having a history of mild TBI (mTBI) will not be excluded.
  6. * Women who are pregnant, breastfeeding, or are within one-year post-partum.
  7. * Current or previous malignancy. A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.
  8. * Current systemic immunologic disorders (e.g. Type 1 diabetes, rheumatoid arthritis). Local immunological disorder (e.g. atopic dermatitis, stable autoimmune thyroid disease) and allergic disorders will be allowed.
  9. * Current or previous long-term immune suppressive therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment
  10. * Any medical condition that would make the study procedures risky for the participant (e.g. congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe osteoarthritis, exercise-induced angina and poorly controlled asthma).
  11. * Active participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.
  12. * Inability to perform the bicycling exercise task. (e.g. coronary artery disease, not having a lower limb, disabling stroke)
  13. * Not willing to allow for research data and samples to be shared broadly with other researchers.
  14. * Symptom severity that makes it impossible for the volunteer to travel to NIH for extended inpatient evaluation
  15. * Use of medications with a high-risk for withdrawal-related complications (i.e. long-acting opiates or benzodiazepines).
  16. * Substantial claustrophobia
  17. * Inability to lie on back for up to 2 hours

Contacts and Locations

Study Contact

Angelique A Gavin
CONTACT
(301) 402-0880
angelique.gavin@nih.gov
Brian T Walitt, M.D.
CONTACT
(301) 496-5043
brian.walitt@nih.gov

Principal Investigator

Brian T Walitt, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

  • Brian T Walitt, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-16
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2023-04-16
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Veteran
  • Gwi (Gulf War Illness)
  • Natural History

Additional Relevant MeSH Terms

  • Gulf War Illness