This project will study 206 veterans with Gulf War Illness (GWI) whose symptoms include chronic pain. The first aspect of this study will evaluate a series of Gulf War One (GW1) veterans to identify individuals with these symptoms which in addition to chronic pain may include respiratory difficulty, gastrointestinal problems, dermatologic problems, chronic fatigue, depression, substance abuse, anxiety, cognitive problems and post- traumatic stress disorder (PTSD). Following screening to determine eligibility and informed consent, veterans will be randomly assigned to treatment or sham (placebo) for the study. Additional examinations will compare brain imaging (PET-FDG) across participants. Also, genetic data will be gathered for a pilot sub-study analysis that examines the PON1 gene relationship with GWI symptomatology To determine whether repetitive Transcranial Magnetic Stimulation (rTMS) can be effective in treating the symptoms of chronic pain among veterans with GWI, this project will evaluate the efficacy, safety, durability of benefits and cost-effectiveness of rTMS in the rehabilitation of Veterans with chronic pain in the context of multiple GWI symptoms. We will specifically compare 103 patients receiving rTMS with 103 sham treated patients. Care will be taken to account for common conditions associated with GWI, including fatigue, gastrointestinal problems, dermatologic problems, respiratory problems, cognitive dysfunction, depression, anxiety disorders, substance abuse, and PTSD. It is the intent of this study to determine if the newly FDA-approved treatment for depression, rTMS, may have some benefit to patients with GWS. The data from this study could be used to justify further research in this area.

Public Health Relevance

This project will study 206 Gulf War 1 (GW1) veterans identified with symptoms understood to characterize Gulf War Illness, including a primary ICD-9 diagnosis fibromyalgia type pain. Following screening and informed consent, veterans will be randomly assigned to treatment with repetitive transcranial magnetic stimulation (rTMS) or sham rTMS (placebo). Additional examinations will compare brain imaging (PET-FDG) across participants. Although the VA population is similar to the general population in many respects, there are important differences. It also differs significantly from the populations that have been included in prior trials of rTMS or many conditions such as Depression, chronic pain and fibromyalgia. Most notably, the veteran population exhibits a 9.6% prevalence rate of fibromyalgia type pain in non-GW1 veterans and a 19.2% prevalence rate of these symptoms in GW1 veterans - compared to a prevalence rate of 2.0% in the general population (Iowa Persian gulf Study Group, 1997;Wolf, Ross, Anderson, Russell and Hebert, 1995).

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
1I01CX000792-01
Application #
8269794
Study Section
Psychological Health & Social Reintegration (RRD4)
Project Start
2012-10-01
Project End
2016-09-30
Budget Start
2012-10-01
Budget End
2013-09-30
Support Year
1
Fiscal Year
2013
Total Cost
Indirect Cost
Name
Veterans Admin Palo Alto Health Care Sys
Department
Type
DUNS #
046017455
City
Palo Alto
State
CA
Country
United States
Zip Code
94304