Vagus Nerve Stimulation for Treating Adults With Severe Fibromyalgia

Completed · Phase 1

Conditions studied: Fibromyalgia

In brief

Fibromyalgia syndrome (FMS) is a long-term disorder that is characterized by widespread body pain and tender points in joints, muscles, tendons, and other soft tissues. Other symptoms associated with the disorder include fatigue and depression. The cause of FMS is unknown, and conventional treatments are often unsuccessful in adequately relieving pain. For people with severe, unrelenting pain, which is referred to as refractory FMS, opioid maintenance therapy may be an option, but it comes with the dangerous potential of addiction and is therefore avoided if possible. Vagus nerve stimulation (VNS), in which a nerve located in the neck receives electrical input, may be an option for providing pain relief. The purpose of this study is to determine the safety, tolerability, and effectiveness of VNS as a treatment for people with refractory FMS.

Key facts

Study ID

NCT00294281

Run by

University of Medicine and Dentistry of New Jersey

People needed

14

Starts

2006-10-01

Expected to finish

2010-06-01

Last updated by the study team

2011-09-20

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of FMS for at least 2 years, as according to the 1990 guidelines of the American College of Rheumatology (ACR) criteria. In addition, ruling out of any other medical illness to which pain may be attributed.
• Inadequate relief in FMS pain despite good treatment efforts using standard pharmacological pain management. Only patients who are work-disabled because of FMS pain are eligible for study participation if they are on opioid maintenance therapy.
• Overall FMS pain at an intensity of 5 or greater on a 0-10 verbally anchored pain intensity scale, on more than 50% of days over a consecutive 7-day period before study entry
• Has not changed pharmacological and/or non-pharmacological (e.g., yoga, exercise) treatment regimen for the 4 weeks before the first study visit and continues to experience severe pain
• At least average premorbid IQ, as assessed by the vocabulary subtest of the WAIS-III, which is a standardized, well-validated index of premorbid intellectual function
• Willing to use an acceptable method of birth control
• Able to comply with all testing and follow-up visit requirements defined by the study protocol
• Currently lives within a 2-hour driving commute to the study site

You may not qualify if…

• Rheumatologic condition other than FMS
• Secondary FMS, in which FMS is comorbid with another rheumatologic condition
• Reports that FMS pain began after a physical trauma
• In litigation that is associated with FMS condition at study entry
• Severe lifetime or current diagnosis of psychotic depression, bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders or has a clear history of other psychiatric illness before the onset of FMS
• Diagnosed with major depressive disorder and has attempted to commit suicide in the past or has active suicidal ideation
• Lifetime or current history of dependence or abuse of pain medication or alcohol
• Treatment with an antipsychotic drug within 3 months of study entry
• Demonstrated a known placebo response in a previous study
• Treatment with botulinum toxin or local steroid injection for FMS within 2 months of study entry
• History of myocardial infarction or cardiac arrest
• Received general anesthesia within 30 days of implantation surgery
• Treatment with an investigational drug within a clearance duration of five times the half-life of the investigational drug or within 4 weeks of study entry
• Currently using another investigational device or drug
• Significant heart or lung condition currently under treatment and resulting in an American Society of Anesthesiologists (ASA) score greater than III
• Unilateral or bilateral cervical vagotomy
• Demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator
• Any of the following conditions if over the age of 50 years old: cardiac conductance abnormalities, Wolf-Parkinson-White Syndrome, surgical intervention for bradycardia, history of prolonged QT interval, or a history of syncopal or pre-syncopal episodes
• Likely to require a whole body MRI after VNS system implantation
• Currently receiving or likely to receive after implantation short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
• Plans to relocate or move to a location distant from the study site within 1 year of study entry
• Previously enrolled in this or any other VNS system study
• Pregnant

Where it is running

• University of Medicine and Dentistry of New Jersey — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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