March 1, 2007
Contact: Larry Parker
Phone: (973) 972-3000
NIH Supports Clinical Trial at UMDNJ for Device for Severe Fibromyalgia
NEWARK — The National Institutes of Health, in Bethesda, Md., have funded a $1.4 million study at the UMDNJ-New Jersey Medical School to investigate a possible treatment for fibromyalgia using a medical device implanted onto the vagus nerve. The study will require 30 volunteers in the New York/New Jersey area for a successful outcome.
Fibromyalgia is a chronic pain disorder that can significantly affect a sufferer’s life. Those with fibromyalgia often visit many medical professionals before being diagnosed with the disorder. Individuals with fibromyalgia often try many traditional and alternative treatments to fight the body pain and sensitivity to touch characterizing this illness. The disorder is often accompanied by depression.
Because there is no cure, the treatment of last resort for pain relief is often the use of morphine and related medicines. “Patients often don’t like to take morphine-based medications and doctors hesitate to prescribe them because of concerns regarding potential dependency,” said Gudrun Lange, Ph.D., a professor in the departments of radiology and psychiatry at NJMS, and researcher in the NJMS Pain and Fatigue Study Center.
Dr. Lange has recently received NIH funding to evaluate the safety and tolerability of vagus nerve stimulation in patients who have not achieved sufficient treatment relief with traditional fibromyalgia treatments. VNS Therapy™ is currently approved by the Food and Drug Administration as an adjunctive treatment for chronic or treatment- resistant depression and for treatment-resistant epilepsy and can be used along with other medications to more effectively treat these conditions.
In VNS Therapy, the left vagus nerve, a nerve running from the brain to major organs, is stimulated using a small pocket watch-sized device implanted under the skin in the left chest area. Another incision is then made on the left side of the neck, so that the surgeon can connect the stimulator with the vagus nerve by wrapping wire coils around the nerve. The procedure generally takes no longer than two hours and is done on an outpatient basis. Eventually, the device is programmed to stimulate the vagus nerve with mild, intermittent electrical pulses. Typically, the device is adjusted to mildly stimulate the vagus nerve in pulses of 30 seconds followed by a five-minute rest period - 24 hours a day, seven days a week. The most common side effect of VNS Therapy is voice alteration, such as hoarseness, during the stimulation period.
The idea of using VNS Therapy to treat severe fibromyalgia pain is based on data from research studies showing that pain sensitivity decreased after VNS Therapy was used in patients with severe forms of epilepsy and depression. VNS Therapy may affect certain regions and chemicals in the brain in a way that may reduce chronic pain symptoms associated with fibromyalgia.
Dr. Lange, leading the study, is supported by an experienced medical team headed by Benjamin H. Natelson, M.D., a professor of neurosciences at NJMS and fibromyalgia expert as well as Allen H. Maniker, M.D., a professor in the department of neurosurgery at NJMS and a neurosurgeon at The University Hospital in Newark with significant VNS surgical experience.
The team will study 30 patients with fibromyalgia, some of whom may also have depression, and some of whom will also be disabled because of fibromyalgia pain. Each study participant will remain in the study for two years. The cost of all medical procedures during the study period will be covered by the study. Enrolled participants must live within two hours commuting distance of the UMDNJ campus in Newark and will be able to continue pain medication while utilizing VNS Therapy for the study. Interested individuals may call the NJMS Pain and Fatigue Study Center at (973) 972-4800, or visit their Web site at http://njms.umdnj.edu/centers_institutes/pain_fatigue/.
UMDNJ is the nation's largest free-standing public health sciences university with more than 5,500 students attending the state's three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and its only school of public health, on five campuses. Last year, there were more than 2 million patient visits to UMDNJ facilities and faculty at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden and Stratford. UMDNJ operates The University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, a mental health and addiction services network.