Status:
COMPLETED
Vagus Nerve Stimulation for Treating Adults With Severe Fibromyalgia
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Fibromyalgia
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
FMS affects about 5% of the general population and occurs most often in women between the ages of 20 and 50 years old. Overall, more than 80% of FMS patients report that pain is the primary symptom th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00294281
Start Date
October 1 2006
End Date
June 1 2010
Last Update
September 20 2011
Active Locations (1)
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1
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States, 07107