NCT00294281

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 20, 2011

Status Verified

July 1, 2010

Enrollment Period

3.6 years

First QC Date

February 16, 2006

Last Update Submit

September 19, 2011

Conditions

Fibromyalgia

Keywords

PainTendernessDepressionWork DisabilityPhysical FunctionQuality of LifeChronic Pain

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Measured at Week 16, which is the acute study exit

Secondary Outcomes (4)

  • FM 20 multidimensional response index (FM 20)

    Measured at Week 16, which is the acute study exit

  • Assessment of pain intensity

    Measured at Week 16, which is the acute study exit

  • Assessment of function

    Measured at Week 16, which is the acute study exit

  • Assessment of patient global perception

    Measured at Week 16, which is the acute study exit

Study Arms (1)

1

EXPERIMENTAL

Participants will undergo surgical implantation of the VNS system. This will be followed by a 2-week recovery period, then a 2-week period of gradually increasing the electrical output of the VNS system, and finally a 12-week VNS treatment period during which the electrical output level will remain constant. Follow-up will occur until Month 24.

Device: Vagus Nerve Stimulation (VNS) Therapy

Interventions

Vagus Nerve Stimulation (VNS) TherapyDEVICE

The VNS Therapy System Pulse Generator is an implantable, multi-programmable bipolar pulse generator. The pulse generator will deliver electrical signals to the vagus nerve via bipolar leads. A programming wand and software system enable non-invasive programming, functional assessments, interrogation, and data retrieval.

1

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07107, United States

Location

Related Publications (1)

  • Lange G, Janal MN, Maniker A, Fitzgibbons J, Fobler M, Cook D, Natelson BH. Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial. Pain Med. 2011 Sep;12(9):1406-13. doi: 10.1111/j.1526-4637.2011.01203.x. Epub 2011 Aug 3.

    PMID: 21812908DERIVED

MeSH Terms

Conditions

FibromyalgiaPainDepressionChronic Pain

Interventions

Vagus Nerve StimulationTherapeutics

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy

Study Officials

  • Gudrun Lange, PhD

    University of Medicine and Dentistry of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 20, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

September 20, 2011

Record last verified: 2010-07

Locations

US(1)