NEW JERSEY - Tuesday, August 20th 2013 [ME NewsWire]
(BUSINESS WIRE)-- A clinical study to evaluate the prophylactic effect of non-invasive vagal nerve stimulation for the prevention of chronic migraine completed enrollment last week. The study, which is being sponsored by electroceutical healthcare company electroCore, involves 60 patients across six US sites1.
After an initial one month period, during which headache frequency data will be collected, the patients, all of whom experience migraine headaches on more than 15 daysper month, will be randomized into two groups. One group will use an active device and the other a sham device for a period of two months. All patients will then be provided with the active treatment device for a period of six months. Throughout the study, patients will record the number of headache days and the severity of the headaches experienced. The full results are expected in the second quarter of 2014.
This study, which is part of one of the largest global clinical programs currently being run in headache, is an FDA approved IDE pilot, double blind, randomized, sham controlled trial. The treatment being studied is electroCore’s gammaCore vagus nerve stimulation therapy, which is delivered by placing the gammaCore against the neck over the vagus nerve. Prior evidence shows that the active device will stimulate the afferent fibres of the vagus nerve which project into the brain stem, where the signal causesthe release of inhibitory neurotransmitters in the brain, including GABA, serotonin, and norepinephirine2.
electroCore’s Chief Operating Officer, Frank Amato commented, "We are grateful to the physicians, sites, and patients with chronic migraine with whom we are working, and pleased that they have now completed the enrollment of this important trial. Next, we look forward to the completion of the follow up phase, and to the opportunity to analyze the data from this study, which extends over a nine month period. This trial is an important piece of the larger multi-trial global program across several primary headache conditions, all of which should read out over the next 12 to 18 months.”
1 University of California, San Francisco; Michigan Headache and Neurological Institute, Ann Arbor; Thomas Jefferson University, Philadelphia.;Carolina Headache Institute, Chapel Hill; Montefiore Medical Center, NY; Headache Care Center, Springfield, MO
2 Beekwilder JP, Beems T. Overview of the clinical applications of vagus nerve stimulation. J Clin Neurophysiol. 2010 Apr; 27 (2): 130-8.