Icahn School of Medicine at Mount Sinai Receives Award From United States Department of Defense For Innovative Treatment of Veterans with Gulf War Illness
Researchers at the Icahn School of Medicine at Mount Sinai have been awarded a U.S. Army Medical Research grant to conduct a study on the use of non-invasive vagus nerve stimulation (nVNS) therapy to treat veterans of the 1990-1991 Gulf War who have Gulf War illness.
The $703,200 grant will be used to fund a randomized clinical trial involving more than 40 veterans who experience widespread pain and migraines, common complaints of Gulf War veterans. The study will be led by Benjamin Natelson, MD, Director of the Pain and Fatigue Study Center at Mount Sinai Beth Israel, an internationally recognized leader in the clinical care of and research into medically unexplained pain and fatigue.
Gulf War illness, a prominent condition affecting Gulf War veterans, is a cluster of medically unexplained chronic symptoms that can include fatigue, headaches, joint pain, indigestion, insomnia, dizziness, respiratory disorders, and memory problems.
While pharmaceutical treatments have become available for the widespread pain and achiness of Gulf War illness, these treatments don’t work on all patients, their effect often does not last more than a few months, and the side effects they produce are often so bad as to preclude their use.
“Vagus nerve stimulation is already an FDA-approved treatment for epilepsy and depression,” says Dr. Natelson, principal investigator of the trial. “The drugs to treat epilepsy and depression are in the same class as newly approved drugs to treat the widespread pain characteristic of fibromyalgia, a common diagnosis in Gulf War veterans, so we are eager to see how these patients will fare in this trial.”
Dr. Natelson and his team previously conducted a safety and tolerability study in 14 women with fibromyalgia who tolerated surgical implantation and activation of an nVNS device. Strikingly, many of the women got so much better that they no longer fulfilled criteria for the diagnosis of fibromyalgia.
For the current study, the research team has partnered with electroCore, a New Jersey based bioelectric pharma company, to use its hand-held gammaCore device, which allows for stimulation of the vagus nerve without the need for surgery. The patient places the device’s stimulator on the skin overlying the vagus nerve in the neck and then turns it on for 90-second periods three times a day. The device is programmed to deliver only six total bouts of stimulation per day – one to each side of the neck three times per day. The device stimulates fibers of the vagus nerve bundle that ascends to the brain to activate pain centers in the brain to reduce pain.
After being measured for pain and headache severity before the treatment, veterans will receive either the actual, active nVNS device, or an inactive device which does not stimulate the nerve. Study participants will then use their device for 10 weeks, periodically responding to questions about the severity of their pain and headaches. During the final phase of the study, all veterans will return to the hospital, where all will receive active devices. Ten weeks later, they return once again to provide information that will allow study investigators to gain further knowledge as to the effectiveness of actual nVNS in relieving pain – both through the body and in the head.
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