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.
Notes to editors
US Army Medical Research
“The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office”
“This work was supported by the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No.W81XWH-15-1-0615. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.”
“In conducting research using animals, the investigator(s) adheres to the laws of the United States and regulations of the Department of Agriculture.”
“In the conduct of research utilizing recombinant DNA, the investigator adhered to NIH Guidelines for research involving recombinant DNA molecules.” (http://www.nih.gov)
“In the conduct of research involving hazardous organisms or toxins, the investigator adhered to the CDC-NIH guide for Biosafety in Microbiological and Biomedical Laboratories.” (http://www.cdc.gov/biosafety)
About the Mount Sinai Health System
The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.
The System includes approximately 7,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is in the “Honor Roll” of best hospitals in America, ranked No. 15 nationally in the 2016-2017 “Best Hospitals” issue of U.S. News & World Report. The Mount Sinai Hospital is also ranked as one of the nation’s top 20 hospitals in Geriatrics, Gastroenterology/GI Surgery, Cardiology/Heart Surgery, Diabetes/Endocrinology, Nephrology, Neurology/Neurosurgery, and Ear, Nose & Throat, and is in the top 50 in four other specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 10 nationally for Ophthalmology, while Mount Sinai Beth Israel, Mount Sinai St. Luke’s, and Mount Sinai West are ranked regionally. Mount Sinai’s Kravis Children’s Hospital is ranked in seven out of ten pediatric specialties by U.S. News & World Report in “Best Children’s Hospitals.
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electroCore LLC, the New Jersey based bioelectric pharma company, is focused on developing non-invasive vagus nerve stimulation therapies (the gammaCore device) for the treatment of multiple conditions in neurology, psychiatry, gastroenterology, and respiratory fields. The company’s initial target is the treatment of primary headaches (migraine and cluster headache), and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders that drive disproportionately large direct and indirect costs within the healthcare system and society. In Germany gammaCore is distributed by Desitin.