The long-term study consists of a six, nine, and twelve month, and annual follow-ups to the surgery date. At this time, study subjects check in with the research team for collection and analysis of longitudinal data.
The original pilot study has completed enrollment. We plan on re-initiating a second, larger study in the near future. Please contact us via email or phone (as listed below) if you are interested in having your name put on a list of individuals to be contacted when the study is re-initiated.
The National Institutes of Health awarded Dr. Faris and her research team at the University of Minnesota, Department of Psychiatry, Division of Neuroscience, $300,000 to investigate the use of Vagus Nerve Stimulation (VNS) therapy in women with bulimia nervosa. Dr. Faris received FDA approval to investigate this therapy in 10 women diagnosed with severe, treatment-resistant bulimia.
VNS therapy aims to reverse the physiological changes that have occurred in the function of the vagus nerve from repeated binge eating and vomiting. The vagus nerve is the main “information highway” from the stomach to the brain. By controlling this nerve’s activity through electrical stimulation, doctors hope to reduce the frequency of vomiting in patients with bulimia.
The study involves the surgical implantation of the VNS therapy system, which has been FDA-approved for use in pharmacoresistant epilepsy. The system is made up of a generator, lead, and electrodes. The generator is the approximate size and shape of a silver dollar and is placed beneath the skin of the patient’s chest where the breast meets the arm. The device is connected, by the lead which is a small, narrow wire, to small electrode coils which are wrapped around the left cervical branch of the vagus nerve in the neck. These coils deliver mild, regularly-timed pulses to the nerve, acting in a pacemaker-like fashion. The VNS therapy system equipment and clinical engineering consultation for all ten research subjects was provided by Cyberonics, Inc.
The short-term study lasts approximately four months. First, individuals are screened over the phone. If eligible from the brief phone screen, interested individuals are invited to come in to discuss details related to study participation. Informed written consent is obtained on this visit from those individuals interested in participating in the study. The first month consists of a baseline period, during which evaluations are conducted to determine eligibility for the study and suitability for surgery. During this period and throughout the entire study, all study subjects call in to a research assistant each day to report meal patterns and bulimic behaviors in addition to keeping their own meal pattern log. These two measures serve as data collection tools. The surgical procedure occurs one month after written consent has been obtained. The procedure is done under general anesthesia and lasts approximately two hours. Two small incisions are made during this procedure: one, about two inches in length, along a horizontal creaseline in the neck and another, also about two inches in length, vertically under the armpit in the axilla. Following the surgery, study subjects recover for two weeks before the device is turned on. Once the device is turned on, two weeks are allotted for the stimulation parameters to be adjusted in order to find a level of stimulation that is both comfortable to the patient and also effective in managing the bulimic symptoms. After the two week adjustment period, eight weeks of constant stimulation follow. During this time, patients come in on a weekly basis to meet with their study psychiatrist and the research team for medical monitoring and data collection. At the end of the eight weeks, subjects exit the short-term study and enter the long-term study.
The long-term study consists of a 6-, 9-, and 12-month, and annual follow-ups to the surgery date. At this time, study subjects check in with the research team for collection and analysis of longitudinal data.
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Contact Information
eating@umn.edu
phone - 1-800-600-8636 - 612-626-4034
fax - 612-624-8935
Address:
University of Minnesota, Dept. of Psychiatry
MMC 392 Mayo, 420 Delaware St. S.E.
Minneapolis, MN 55455