This is a proposal to conduct a clinical study to evaluate the efficacy and safety of a novel therapy to treat chronic pain conditions in veterans with Gulf War illness. Gulf War illness often results in fibromyalgia symptoms such as chronic muscle pain, fatigue, tension, and migraine. These complaints delay Soldiers from returning to duty or result in early discharge. An estimated 26%-32% of the 697,000 Veterans deployed to the 1991 Persian Gulf War experience multi-symptom conditions that cannot be explained by stress or psychiatric illness.

For more than a decade, many Gulf War illness pharmacological and non-pharmacological treatments have only benefitted a small subset of patients, while most of these patients remain non-compliant to treatment. To address this unmet need, we propose a novel method that modulates abnormal neural activity responsible for the pain symptoms. It is now accepted that abnormal neural activity is very likely responsible for Gulf War illness and often results in pain symptoms.

Our therapeutic method consists of noninvasive stimulation of the brain to induce therapeutic changes in neural activity related to pain complaints. Our studies in pain symptoms in fibromyalgia patients suggest that our therapy can in fact suppress abnormal neuronal activity in the brain. We see no evidence that the complaint returns even weeks after the therapy is discontinued, suggesting that our therapy will be long-lasting (multiple weeks or more). To the best of our knowledge, no previous study has ever shown a large suppression and long-lasting reversal of pain symptoms in fibromyalgia. This has encouraged us to test this therapy in Veterans with Gulf War illness suffering from pain symptoms. Our brain stimulation therapy is known to be safe and effective in humans; therefore, our therapy is ready for a clinical trial.

Our proposed clinical trial is designed to test the efficacy and safety of our therapy in Veterans with Gulf War illness. This clinical trial will look at the effectiveness of noninvasive brain stimulation for improving pain complaints, providing a new noninvasive, non-pharmacological treatment in Gulf War illness patients with few side effects or drug interactions. Due to minimal technical and therapeutic requirements, our therapy could easily be applied at any clinical site, including theater military bases. This treatment will be immediately available for use, could be added to other medical treatment regimens, and could potentially lead to development of other targets for stimulation to improve other deficits in Gulf War illness.