Mount Sinai Beth Israel Receive Award from the Department of Defense to Study Gulf War Illness with electroCore’s Non-Invasive Vagus Nerve Stimulation Therapy

Basking Ridge, NJ, November 17, 2016 --( The Pain & Fatigue Study Center at Mount Sinai Beth Israel in New York has been awarded a United States Army Medical Research grant to conduct a study into the treatment of veterans of the 1990-1991 Gulf War who have Gulf War Illness using electroCore’s non-invasive vagus nerve stimulation (nVNS) therapy gammaCore. The $703,272 grant will be used to fund a randomized clinical trial involving more than 40 veterans with widespread pain and migraines, a common complaint of gulf war veterans.

This study will be led by Benjamin Natelson MD, an internationally recognized leader in clinical care and research into medically unexplained pain and fatigue. The trial will be conducted at the Pain & Fatigue Study Center at Mount Sinai Beth Israel in Manhattan.

“While pharmaceutical treatments are available for the treatment of Gulf War Illness, they have drawbacks,” says Dr. Natelson. “These drugs don’t work for all patients, the effect frequently only lasts a couple of months and the side effects are often so severe as to preclude their use so there is a real need for further research into treatment of this debilitating condition.”

Having been previously involved with surgically implanted vagus nerve stimulation (VNS), in a fibromyalgia safety and tolerability study which resulted in several of the patients becoming pain free, Dr Natelson was keen to run a randomized sham controlled trial to rule out a placebo effect and to determine whether non-invasive VNS could be effective in gulf war illness.

“VNS is already an FDA-approved treatment for epilepsy and depression and the drugs used 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,” says Dr Natelson.

ElectroCore's proprietary, non-invasive electrical stimulation therapy works by the patient placing the device on the skin over the vagus nerve in the neck. This activates the fibers of the vagus nerve bundle that ascend to the brain to activate pain-related centers. The result of this activation is reduced pain.

In the first phase of the study, veterans will be assessed for body-wide pain and headache. In the second phase half of the veterans will be given an active gammaCore nVNS device, and half will be given a sham (inactive) device. These devices will be used by the veterans three times a day for ten weeks, with periodic assessments of the severity of their pain and headaches. After the randomized phase, all veterans will receive active gammaCore devices to use for a further ten weeks in an open label phase. The final assessment of the study, lasting 20 weeks in total, will provide the investigators with information about the effectiveness of nVNS therapy in relieving both widespread pain and migraine headaches.

Should the study produce results of sufficient interest, the United States Army has indicated that it will strongly consider supporting a larger pivotal study into VNS therapy for the treatment of widespread pain in Gulf War Illness.
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