Treatment Studies
Vagus Nerve Stimulation in Fibromyalgia
Study to determine safety and tolerability of a device to relieve pain.
Study Device: Vagus Nerve Stimulator (VNS)
Sponsors: University of Medicine and Dentistry New Jersey
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Manufacturer: Cyberonics, Inc.
FDA Status: The vagus nerve stimulator was approved in 1997 to reduce seizures in people with epilepsy and is also approved now for depression in patients who do not respond to medications
Basic Info: VNS therapy targets the part of the vagus nerve that travels from the neck region into the brain. This part of the nerve carries sensory/pain-related information to the brain, which can influence a variety of actions in the various structures in the brain. It is hoped that the VNS can be used as a portal into the brain to reduce pain and improve the quality of life in people with fibromyalgia. To proceed toward testing the effectiveness of VNS therapy in fibromyalgia patients, researchers must first determine its safety and tolerability. This battery-powered device is surgically implanted below the collarbone in the same manner as a cardiac pace maker in an outpatient procedure. A wire from the stimulator is then wrapped around the left vagus nerve for stimulation. The VNS is an "add-on" type of trial because participants do not have to go off their medications (although they must be on stable doses).
Recruiting for Phase II Trial: Fibromyalgia patients are asked to participate in this VNS pilot study for at least one year, with possible follow-up extending to two years. The study is seeking 30 participants for this non-randomized, open label, uncontrolled, single group assignment. The primary purpose of this trial is to evaluate the safety and tolerability of the VNS in a sample of patients with severe fibromyalgia, and compare this data to patients with epilepsy and depression. The secondary purpose of this study is to determine the impact of VNS therapy on the symptoms of fibromyalgia, including pain, physical function, mood, and quality of life. If the VNS is found safe and tolerable, this study will be used to identify the required settings needed to best treat fibromyalgia so that a Phase III trial can be initiated.
Previous Test Results: In preliminary studies involving patients with epilepsy and depression, many noted the VNS provided pain relief as a side effect. In a subsequent study, patients with depression were able to tolerate higher pain thresholds using the VNS.1 It also has been shown to benefit epilepsy patients with persistent migraines.2 Intolerance to VNS appears to be rare, but there are potential side effects such as hoarseness, cough, change in voice, and feeling short of breath during exertion. Again, the VNS is used as an additional therapy to what participants are already using to control their fibromyalgia symptoms.
Study Criteria (key requirements):
- male or female, 21 to 60 years of age
- must meet the diagnostic criteria for fibromyalgia syndrome at least two years and cannot have another rheumatologic condition
- hard or impossible to manage symptoms resisting ordinary methods of treatment. Patients have failed to find relief after using nonsteroidal anti-inflammatory drugs, tricyclic antidepressants (such as Elavil, Flexeril, etc.), at least one anti-epileptic drugs (such as Lyrica, Neurontin, etc.), and a short-acting analgesic, Ultram/tramadol.
- must be on stable medication types and doses for four weeks prior to the study. Medication can be decreased but not increased during the 16 weeks after the implant.
- does not have psychiatric illness (current or past history of depression is okay)
- does not have any heart condition
- must be located within a two-hour driving distance of the study site due to the frequent number of office visits required
Study Location: University of Medicine and Dentistry of New Jersey, Newark
Contacts:
Jennifer FitzGibbons
Phone: (973) 972-4800 • E-mail: fitzgijd@umdnj.eduMalusha Fobler
Phone: (973) 972-4800 • E-mail: foblerm@umdnj.eduGudrun Lange, Ph.D.
Phone: (973) 972-4800 • E-Mail: langegu@umdnj.edu
Click here for more details on the vagus nerve stimulation study.
1. Borckardt JJ, el at. Pain Res Manage 10 (1):9-14, 2005
2. Hord ED, et. al. J Pain 4 (9):534-4, 2003.
The Fibromyalgia Network is not in any way associated with any clinical trials, pharmaceutical companies, device manufacturers, or government agencies. As a self-help organization, we accept no sponsorship, advertisements, or government funds. The information on these pages is provided as a public service.
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