Gulf War Illness (GWI) has been a recognized consequence of fighting the first Gulf War since spring of 1991. This study presents a plan to test a new treatment to improve the widespread pain reported by many Gulf veterans – a hand-held device that stimulates the vagus nerve in the neck.
This is a prospective, double-blind, randomized, sham-controlled study [“blinded” phase of trial] followed by an open label phase to collect clinical data related to the use of non-invasive vagus nerve stimulation (nVNS) with the gammaCore®-R device for the treatment of the widespread pain seen in Gulf War Illness and for the treatment of migraine if it co-exists with the widespread pain. The study compares the safety and effectiveness of an active nVNS against a sham nVNS device (no current generated) and measures changes in self-reported pain severity, overall clinical impression of change, and physical function.
This is a multi-center study conducted between the War Related Illness & Injury Study Center (WRIISC) and Dr. Benjamin Natelson at Mount Sinai Downtown, formerly Beth Israel Medical Center and Mount Sinai Beth Israel (MSBI).
Do you experience widespread pain? Headaches/migraines? Fatigue? Gulf War Illness?
This study seeks veterans who served in Operation Desert Shield/Operation Desert Storm and have symptoms of Gulf War Illness.
If chosen, you will make one visit to the War Related Illness & Injury Study Center (WRIISC) in East Orange, NJ, and complete four short sessions over the phone. You must make three visits to Mount Sinai Beth Israel, NYC, and 14 sessions over the phone. You will complete questionnaires, electrocardiogram, history, and physical. You will learn to use a non-invasive vagal nerve stimulator.
Call the War Related Illness & Injury Study Center and ask for the VNS Study – 800-248-8005.